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Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359473
Recruitment Status : Completed
First Posted : December 2, 2017
Results First Posted : July 15, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cachexia
Interventions Drug: GSK2881078
Drug: Matching Placebo
Enrollment 97
Recruitment Details This was a Phase II, double-blind, randomized, multicenter study to evaluate the safety and efficacy of GSK2881078 over 13 weeks of once daily oral dosing, first time administered in older men and post-menopausal female participants with chronic obstructive pulmonary disease (COPD) and muscle weakness, participating in home exercise.
Pre-assignment Details A total of 200 participants were screened and 97 participants were enrolled in this study. Of which, 96 participants were randomized and received the study treatment. The remaining 1 participant was randomized without fulfilling the inclusion and exclusion criteria and therefore did not receive study medication.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks. Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks. Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks. Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Period Title: Overall Study
Started 23 24 24 25
Completed 21 18 18 20
Not Completed 2 6 6 5
Reason Not Completed
Adverse Event             0             2             5             3
Lost to Follow-up             0             1             0             0
Physician Decision             0             1             0             1
Withdrawal by Subject             1             2             1             0
Protocol-defined stopping criteria             1             0             0             1
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants Total
Hide Arm/Group Description Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks. Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks. Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks. Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks. Total of all reporting groups
Overall Number of Baseline Participants 23 24 24 25 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 24 participants 24 participants 25 participants 96 participants
64.7  (7.16) 64.2  (7.93) 64.0  (7.27) 67.2  (6.08) 65.1  (7.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 24 participants 25 participants 96 participants
Female
23
 100.0%
24
 100.0%
0
   0.0%
0
   0.0%
47
  49.0%
Male
0
   0.0%
0
   0.0%
24
 100.0%
25
 100.0%
49
  51.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 24 participants 25 participants 96 participants
Black or African American
0
   0.0%
1
   4.2%
2
   8.3%
2
   8.0%
5
   5.2%
White-White/Caucasian/European Heritage
23
 100.0%
23
  95.8%
22
  91.7%
23
  92.0%
91
  94.8%
1.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP were measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Safety Population comprised of all randomized participants who received at least one dose of study medication. This population was based on the treatment the participant received.
Time Frame Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 22 23 23 24
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP,Day 14,n=22,23,23,24 Number Analyzed 22 participants 23 participants 23 participants 24 participants
3.0  (19.63) 2.1  (11.03) -2.1  (9.33) 3.1  (11.65)
SBP,Day 28,n=22,20,23,24 Number Analyzed 22 participants 20 participants 23 participants 24 participants
3.7  (12.76) -0.1  (12.82) 2.6  (14.39) 5.8  (9.49)
SBP,Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
3.3  (14.96) 7.8  (16.38) -2.4  (17.68) 1.3  (9.12)
SBP,Day 90,n=21,18,18,20 Number Analyzed 21 participants 18 participants 18 participants 20 participants
1.0  (14.23) 7.6  (15.56) -4.2  (18.52) 5.8  (18.61)
DBP,Day 14,n=22,23,23,24 Number Analyzed 22 participants 23 participants 23 participants 24 participants
1.9  (6.88) 1.1  (6.93) -3.4  (6.20) -0.4  (7.47)
DBP,Day 28,n=22,20,23,24 Number Analyzed 22 participants 20 participants 23 participants 24 participants
3.6  (7.08) 1.4  (7.58) 0.7  (7.90) 1.0  (5.36)
DBP,Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
2.1  (7.00) 2.9  (6.07) -2.5  (10.38) -1.6  (8.16)
DBP,Day 90,n=21,18,18,20 Number Analyzed 21 participants 18 participants 18 participants 20 participants
-1.0  (6.47) 2.9  (8.37) -0.1  (12.98) 0.6  (6.95)
2.Primary Outcome
Title Change From Baseline in Heart Rate
Hide Description Heart rate was measured in a seated position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 22 23 23 24
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 14,n=22,23,23,24 Number Analyzed 22 participants 23 participants 23 participants 24 participants
-0.7  (9.79) 3.3  (9.16) 1.7  (10.61) -0.4  (6.60)
Day 28,n=22,20,23,24 Number Analyzed 22 participants 20 participants 23 participants 24 participants
2.2  (8.11) 2.1  (9.64) 4.6  (10.71) -1.7  (10.71)
Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
0.2  (8.87) -1.0  (8.81) 2.8  (7.17) 0.2  (6.36)
Day 90,n=21,18,18,20 Number Analyzed 21 participants 18 participants 18 participants 20 participants
1.1  (7.99) 2.3  (10.34) 7.4  (10.23) -0.6  (8.17)
3.Primary Outcome
Title Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF) and QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB)
Hide Description Twelve-lead electrocardiograms (ECG) were obtained using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 14, 28, 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 22 23 23 24
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR interval,Day 14,n=22,23,22,24 Number Analyzed 22 participants 23 participants 22 participants 24 participants
-1.303  (9.9261) -0.377  (7.2588) -2.455  (12.6556) -2.875  (24.3370)
PR interval,,Day 28,n=22,20,22,24 Number Analyzed 22 participants 20 participants 22 participants 24 participants
-0.061  (7.9340) -4.717  (19.3177) -2.333  (17.5966) 4.139  (15.5796)
PR interval,,Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
1.302  (12.1220) 0.596  (6.5250) 0.483  (7.5436) 10.444  (27.5133)
PR interval,,Day 90,n=21,18,17,20 Number Analyzed 21 participants 18 participants 17 participants 20 participants
-0.270  (9.3111) -6.167  (28.9117) -3.373  (9.6845) 3.033  (20.7947)
QRS Duration,Day 14,n=22,23,23,24 Number Analyzed 22 participants 23 participants 23 participants 24 participants
4.364  (22.8107) 1.362  (10.4736) -0.464  (7.4791) 1.167  (4.1772)
QRS Duration,Day 28,n=22,20,23,24 Number Analyzed 22 participants 20 participants 23 participants 24 participants
1.000  (7.7014) 6.200  (28.2707) -1.478  (5.5047) -0.542  (3.3547)
QRS Duration,Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
-0.095  (5.9639) 1.842  (5.4096) -1.100  (4.9631) -0.413  (4.6271)
QRS Duration,Day 90,n=21,18,18,20 Number Analyzed 21 participants 18 participants 18 participants 20 participants
-2.397  (14.1494) -2.444  (4.5360) 1.333  (25.4163) 1.333  (6.3005)
QT Interval,Day 14,n=22,23,23,24 Number Analyzed 22 participants 23 participants 23 participants 24 participants
0.576  (19.8239) -14.290  (17.7216) -0.638  (22.5431) -0.597  (15.5697)
QT Interval,Day 28,n=22,20,23,24 Number Analyzed 22 participants 20 participants 23 participants 24 participants
-1.333  (23.5300) -16.133  (26.2775) -4.203  (23.3733) -1.750  (22.6539)
QT Interval,Day 56,n=21,19,20,21 Number Analyzed 21 participants 19 participants 20 participants 21 participants
-0.127  (13.5567) -13.947  (18.3657) -1.533  (20.5897) -1.857  (14.6881)
QT Interval,Day 90,n=21,18,18,20 Number Analyzed 21 participants 18 participants 18 participants 20 participants
4.063  (16.9160) -16.352  (20.7511) -4.574  (17.1825) -5.167  (17.7759)
QTcF Interval,Day 14,n=21,21,21,21 Number Analyzed 21 participants 21 participants 21 participants 21 participants
1.749  (11.7762) -7.143  (9.2710) -1.235  (11.3507) -2.698  (9.7085)
QTcF Interval,Day 28,n=21,19,21,21 Number Analyzed 21 participants 19 participants 21 participants 21 participants
0.362  (15.7742) -12.930  (11.7707) -0.489  (10.5492) -4.340  (12.8445)
QTcF Interval,Day 56,n=20,18,18,18 Number Analyzed 20 participants 18 participants 18 participants 18 participants
1.333  (8.5039) -12.222  (10.2975) 1.093  (10.0462) -3.357  (10.5127)
QTcF Interval,Day 90,n=20,17,18,17 Number Analyzed 20 participants 17 participants 18 participants 17 participants
3.600  (10.3526) -12.627  (11.5776) 2.657  (12.2002) -11.804  (11.7207)
QTcB Interval,Day 14,n=4,5,4,7 Number Analyzed 4 participants 5 participants 4 participants 7 participants
-4.333  (26.2100) 2.193  (12.5624) 12.917  (13.6582) 0.571  (11.0180)
QTcB Interval,Day 28,n=4,3,4,7 Number Analyzed 4 participants 3 participants 4 participants 7 participants
-1.167  (12.1549) 13.667  (24.7678) -7.667  (8.8192) -10.238  (11.6678)
QTcB Interval,Day 56,n=3,3,4,6 Number Analyzed 3 participants 3 participants 4 participants 6 participants
-13.556  (11.3741) -7.667  (9.7125) 13.417  (8.0017) -9.500  (7.2411)
QTcB Interval,Day 90,n=3,3,2,6 Number Analyzed 3 participants 3 participants 2 participants 6 participants
1.333  (15.9199) -13.111  (3.0972) 32.000  (1.4142) -10.278  (9.6088)
4.Primary Outcome
Title Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lympho), neutrophil count (Neutro) and platelet count (PC). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Time Frame Baseline (Day 1, Pre-dose) and up to Day 132
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 23 22 24 25
Measure Type: Count of Participants
Unit of Measure: Participants
Hb, Anemia, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hb, Anemia, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hb, Hb increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hb, Hb increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lympho, Lymph count decreased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lympho, Lymph count decreased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lympho, Lymph count increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lympho, Lymph count increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutro,Neutro count decreased,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutro,Neutro count decreased,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC, PC decreased,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC, PC decreased,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC, PC increased,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PC, PC increased,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry Parameters
Hide Description Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin (Bil),calcium (Ca), cholesterol (Chol), creatinine (Creat), glucose(Gl), phosphate (Phos), potassium (Pot) and sodium (Sod). The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Values (Hyper and hypo) for Ca, Gl, Pot, Phos and Sod is presented. Only those participants with increase to grade 3 and increase to grade 4 are presented.
Time Frame Baseline (Day 1, Pre-dose) and up to Day 132
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 23 22 24 25
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, ALT increased, increase to Grade 3
0
   0.0%
1
   4.5%
0
   0.0%
1
   4.0%
ALT, ALT increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, ALP increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, ALP increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, AST increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, AST increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bil, Blood Bil increased, increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bil, Blood Bil increased, increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ca, Hyper,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ca, Hyper,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ca, Hypo,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ca, Hypo,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chol, Chol high,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chol, Chol high,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creat, Creat increased,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creat, Creat increased,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gl, Hyper,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
Gl, Hyper,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gl, Hypo,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gl, Hypo,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phos, Hyper,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phos, Hyper,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phos, Hypo,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phos, Hypo,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pot, Hyper,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pot, Hyper,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pot, Hypo,increase to Grade 3
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
Pot, Hypo,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hyper,increase to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hyper,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hypo,increase to Grade 3
2
   8.7%
0
   0.0%
0
   0.0%
0
   0.0%
Sod, Hypo,increase to Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; Specific Gravity: Placebo-Female Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 28, 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 28,n=1 Number Analyzed 1 participants
0.0030 [1]   (NA)
Day 56,n=1 Number Analyzed 1 participants
0.0020 [1]   (NA)
Day 90,n=21 Number Analyzed 21 participants
-0.0006  (0.00612)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
7.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; Specific Gravity: GSK2881078 1.0 mg- Female Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 14 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2881078 1.0 mg- Female Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 14,n=1 Number Analyzed 1 participants
0.000 [1]   (NA)
Day 90,n=18 Number Analyzed 18 participants
0.0049  (0.00711)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
8.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; Specific Gravity: Male Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 28 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 28,n=1,1 Number Analyzed 1 participants 1 participants
-0.0080 [1]   (NA) 0.0040 [1]   (NA)
Day 90,n=19,20 Number Analyzed 19 participants 20 participants
0.0017  (0.00870) 0.0018  (0.00610)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
9.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH): Placebo- Female Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 28, 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: pH
Day 28,n=1 Number Analyzed 1 participants
0.0000 [1]   (NA)
Day 56,n=1 Number Analyzed 1 participants
-0.5000 [1]   (NA)
Day 90,n=21 Number Analyzed 21 participants
0.0000  (0.80623)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
10.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; pH: GSK2881078 1.0 mg- Female Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 14 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK2881078 1.0 mg- Female Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: pH
Day 14,n=1 Number Analyzed 1 participants
1.0000 [1]   (NA)
Day 90,n=18 Number Analyzed 18 participants
-0.1111  (0.60768)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
11.Primary Outcome
Title Change From Baseline in Urinalysis Parameter; pH: Male Participants
Hide Description Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Days 28 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: pH
Day 28,n=1,1 Number Analyzed 1 participants 1 participants
1.0000 [1]   (NA) 0.5000 [1]   (NA)
Day 90,n=19,20 Number Analyzed 19 participants 20 participants
-0.1579  (0.72749) 0.3000  (0.71451)
[1]
Standard deviation could not be calculated as a single participant was analyzed.
12.Primary Outcome
Title Number of Participants With Urinalysis Dipstick Results Post-Baseline Relative to Baseline
Hide Description Urine samples were collected to analyze parameters including glucose, occult blood (OB) and protein levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Time Frame Baseline (Day 1, Pre-dose) and up to Day 132
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 23 21 23 24
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose: increase to trace
0
   0.0%
0
   0.0%
1
   4.3%
0
   0.0%
Glucose: increase to 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose: increase to 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose: increase to 3+
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
OB: increase to trace
1
   4.3%
0
   0.0%
1
   4.3%
1
   4.2%
OB: increase to 1+
1
   4.3%
1
   4.8%
1
   4.3%
0
   0.0%
OB: increase to 2+
1
   4.3%
2
   9.5%
0
   0.0%
0
   0.0%
OB: increase to 3+
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
Protein: increase to trace
2
   8.7%
2
   9.5%
3
  13.0%
6
  25.0%
Protein: increase to 1+
0
   0.0%
3
  14.3%
1
   4.3%
3
  12.5%
Protein: increase to 2+
0
   0.0%
1
   4.8%
0
   0.0%
1
   4.2%
Protein: increase to 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and non-SAEs are presented.
Time Frame Up to Day 132
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 23 24 24 25
Measure Type: Count of Participants
Unit of Measure: Participants
Non-SAEs
15
  65.2%
18
  75.0%
13
  54.2%
17
  68.0%
SAEs
1
   4.3%
2
   8.3%
2
   8.3%
0
   0.0%
14.Primary Outcome
Title Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value]. Adjusted means and standard error (SE) are presented. Analysis Population comprised of the participants in the 'All Participants (all randomized participants who received at least one dose of study medication)' Population having Baseline and at least one post-Baseline assessment of the treatment the participant was randomized to.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 20 22 23
Mean (Standard Error)
Unit of Measure: Percentage change
4.82  (2.406) 9.34  (2.459) 1.55  (2.940) 9.35  (2.848)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.53
Confidence Interval (2-Sided) 90%
-1.30 to 10.36
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.80
Confidence Interval (2-Sided) 90%
0.83 to 14.76
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
15.Primary Outcome
Title Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value]. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 20 18 21 21
Mean (Standard Error)
Unit of Measure: Percentage change
0.08  (2.787) 16.78  (2.925) 5.73  (3.921) 11.07  (3.922)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 16.71
Confidence Interval (2-Sided) 90%
9.86 to 23.56
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.35
Confidence Interval (2-Sided) 90%
-4.09 to 14.78
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
16.Primary Outcome
Title Percentage Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value]. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 18 18 20
Mean (Standard Error)
Unit of Measure: Percentage change
12.76  (4.061) 17.93  (4.179) 7.15  (2.759) 14.17  (2.632)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.17
Confidence Interval (2-Sided) 90%
-4.67 to 15.01
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.02
Confidence Interval (2-Sided) 90%
0.46 to 13.58
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
17.Primary Outcome
Title Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 28
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 20 22 23
Mean (Standard Error)
Unit of Measure: Kilograms
4.2  (3.01) 10.0  (3.08) 3.0  (5.06) 16.5  (4.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.9
Confidence Interval (2-Sided) 90%
-1.4 to 13.2
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.5
Confidence Interval (2-Sided) 90%
1.6 to 25.5
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
18.Primary Outcome
Title Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 56
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 20 18 21 21
Mean (Standard Error)
Unit of Measure: Kilograms
0.6  (4.29) 21.3  (4.50) 8.3  (7.69) 15.7  (7.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 20.7
Confidence Interval (2-Sided) 90%
10.1 to 31.2
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.3
Confidence Interval (2-Sided) 90%
-11.1 to 25.8
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
19.Primary Outcome
Title Change From Baseline in Maximum Leg Press Strength Following 1 Repetition Maximum (1-RM) at Day 90
Hide Description Lower extremity strength was measured as 1-RM on a leg press device. Participants continued with a one set of 5 to 10 repetitions of lifting weights using 40 to 60% of estimated maximum, after warm up. Participants, then lifted progressively heavier weights in steps, with each step separated by an appropriate rest period, until participant could not complete the lift. The last successfully completed lift was recorded as the 1-RM. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 18 18 20
Mean (Standard Error)
Unit of Measure: Kilograms
12.3  (4.31) 20.3  (4.45) 14.2  (5.17) 26.0  (4.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.0
Confidence Interval (2-Sided) 90%
-2.5 to 18.4
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.8
Confidence Interval (2-Sided) 90%
-0.5 to 24.0
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline leg press strength, with Day as the repeated factor.
20.Secondary Outcome
Title Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 20 22
Mean (Standard Error)
Unit of Measure: Kilograms
-0.240  (0.0974) 0.642  (0.1023) 0.055  (0.1920) 0.346  (0.1831)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.882
Confidence Interval (2-Sided) 90%
0.643 to 1.121
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.291
Confidence Interval (2-Sided) 90%
-0.156 to 0.738
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
21.Secondary Outcome
Title Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 17 17 18
Mean (Standard Error)
Unit of Measure: Kilograms
-0.134  (0.1410) 0.848  (0.1540) -0.464  (0.1887) 0.663  (0.1829)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.982
Confidence Interval (2-Sided) 90%
0.629 to 1.334
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.127
Confidence Interval (2-Sided) 90%
0.682 to 1.571
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
22.Secondary Outcome
Title Change From Baseline in Appendicular Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Appendicular lean mass was calculated from the regional lean mass measurements of the arms and legs using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 17 15 18
Mean (Standard Error)
Unit of Measure: Kilograms
-0.434  (0.1657) 0.946  (0.1818) -0.225  (0.2306) 0.899  (0.2117)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.380
Confidence Interval (2-Sided) 90%
0.964 to 1.795
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.124
Confidence Interval (2-Sided) 90%
0.594 to 1.654
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline appendicular lean mass, with Day as the repeated factor.
23.Secondary Outcome
Title Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 28
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 20 22
Mean (Standard Error)
Unit of Measure: Kilograms
-0.017  (0.2004) 1.150  (0.2106) 0.075  (0.3004) 0.998  (0.2869)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.167
Confidence Interval (2-Sided) 90%
0.677 to 1.658
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.923
Confidence Interval (2-Sided) 90%
0.222 to 1.623
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
24.Secondary Outcome
Title Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 56
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 17 17 18
Mean (Standard Error)
Unit of Measure: Kilograms
-0.564  (0.2372) 1.522  (0.2587) -0.373  (0.3820) 1.327  (0.3700)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.085
Confidence Interval (2-Sided) 90%
1.493 to 2.678
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.700
Confidence Interval (2-Sided) 90%
0.801 to 2.600
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
25.Secondary Outcome
Title Change From Baseline in Total Lean Mass as Assessed by Dual-energy X-ray Absorptiometry (DXA) at Day 90
Hide Description Participants were asked to lie on a padded platform while a mechanical arm passed over their body. Total lean mass was measured using DXA. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 17 15 18
Mean (Standard Error)
Unit of Measure: Kilograms
-0.531  (0.3349) 1.577  (0.3666) -0.424  (0.5056) 1.689  (0.4666)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.108
Confidence Interval (2-Sided) 90%
1.271 to 2.945
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.113
Confidence Interval (2-Sided) 90%
0.949 to 3.277
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline total lean mass, with Day as the repeated factor.
26.Secondary Outcome
Title Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 28
Hide Description Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores <=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 20 22 23
Mean (Standard Error)
Unit of Measure: Scores on a scale
0.3  (0.25) 0.4  (0.26) 0.2  (0.19) 0.3  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-0.6 to 0.6
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-0.4 to 0.5
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
27.Secondary Outcome
Title Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 56
Hide Description Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores <=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 21 21
Mean (Standard Error)
Unit of Measure: Scores on a scale
0.4  (0.24) 0.4  (0.25) 0.1  (0.24) 0.4  (0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
-0.6 to 0.6
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 90%
-0.2 to 0.9
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
28.Secondary Outcome
Title Change From Baseline in Total Short Physical Performance Battery (SPPB) Score at Day 90
Hide Description Participants were assessed for balance, time for chair rise and gait speed. These are the three components of SPPB. Each component was scored from 0 to 4. The total SPPB score was calculated by taking sum of scores of all 3 components, which ranged from 0 (worst performance) to 12 (best performance). Higher scores indicated better performance. Scores 10 to 12 indicated 'fit/normal' and scores <=7 indicated frail participant. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 18 18 20
Mean (Standard Error)
Unit of Measure: Scores on a scale
0.3  (0.26) 0.5  (0.28) 0.4  (0.23) 0.5  (0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) 90%
-0.4 to 0.9
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 90%
-0.5 to 0.6
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline SPPB total score, with Day as the repeated factor.
29.Secondary Outcome
Title Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 28
Hide Description 'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 20 22 23
Mean (Standard Error)
Unit of Measure: Seconds
-0.644  (0.6333) -1.196  (0.6491) -0.464  (0.3841) -0.537  (0.3763)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.553
Confidence Interval (2-Sided) 90%
-2.082 to 0.977
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.073
Confidence Interval (2-Sided) 90%
-0.977 to 0.832
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
30.Secondary Outcome
Title Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 56
Hide Description 'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 21 21
Mean (Standard Error)
Unit of Measure: Seconds
-1.207  (0.5912) -2.023  (0.6124) -0.323  (0.5294) -0.160  (0.5282)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.816
Confidence Interval (2-Sided) 90%
-2.252 to 0.619
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.163
Confidence Interval (2-Sided) 90%
-1.096 to 1.422
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
31.Secondary Outcome
Title Change From Baseline in 'Time for Chair Rise' as Assessed by SPPB at Day 90
Hide Description 'Time for chair rise' is one of the 3 components of SPPB, which was assessed by repeated chair stand test and calculated as time for five successful chair stands measured in seconds. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 18 18 20
Mean (Standard Error)
Unit of Measure: Seconds
-1.070  (0.6956) -2.030  (0.7362) 1.144  (1.4013) -0.793  (1.3401)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.960
Confidence Interval (2-Sided) 90%
-2.668 to 0.748
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.937
Confidence Interval (2-Sided) 90%
-5.208 to 1.333
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.
32.Secondary Outcome
Title Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 28
Hide Description ''Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 20 22 23
Mean (Standard Error)
Unit of Measure: Seconds
-0.236  (0.1132) -0.277  (0.1161) -0.167  (0.1133) -0.110  (0.1108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.040
Confidence Interval (2-Sided) 90%
-0.314 to 0.233
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.058
Confidence Interval (2-Sided) 90%
-0.209 to 0.324
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
33.Secondary Outcome
Title Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 56
Hide Description 'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 21 21
Mean (Standard Error)
Unit of Measure: Seconds
0.010  (0.1487) -0.276  (0.1560) -0.093  (0.1437) -0.284  (0.1438)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.287
Confidence Interval (2-Sided) 90%
-0.650 to 0.077
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.191
Confidence Interval (2-Sided) 90%
-0.534 to 0.152
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
34.Secondary Outcome
Title Change From Baseline in 'Time for Fastest Walk for 4 Meter' as Assessed by SPPB at Day 90
Hide Description 'Time for fastest walk for 4 meter' was assessed by SPPB using 4 meter gait speed test. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Analysis was performed using mixed model repeated measures. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 18 18 20
Mean (Standard Error)
Unit of Measure: Seconds
-0.043  (0.2194) -0.055  (0.2361) -0.130  (0.1331) -0.360  (0.1275)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.012
Confidence Interval (2-Sided) 90%
-0.555 to 0.532
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.231
Confidence Interval (2-Sided) 90%
-0.541 to 0.080
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.
35.Secondary Outcome
Title Change From Baseline in Constant Work Rate (CWR) Duration From Endurance Shuttle Walking Test
Hide Description The endurance shuttle walk test is a CWR test requiring the participant to walk around a flat 10 meter track at a constant individualized pace. The test was externally paced, set to elicit a maximal exercise response (pace was based on a fixed percentage of prior incremental shuttle walk test performance, which determined a participant's peak exercise capacity). CWR duration is the time in seconds required by a participant to cover a flat 10 meter track during this test. Day 1 (Pre-dose) was considered as a Baseline. Analysis was performed using analysis of covariance (ANCOVA) model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 16 18 20
Least Squares Mean (Standard Error)
Unit of Measure: Seconds
-6.5  (26.78) 4.6  (29.25) 105.1  (54.94) -44.2  (51.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Square Means
Estimated Value 11.1
Confidence Interval (2-Sided) 90%
-57.1 to 79.2
Estimation Comments Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Square Means
Estimated Value -149.3
Confidence Interval (2-Sided) 90%
-280.6 to -18.1
Estimation Comments Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.
36.Secondary Outcome
Title Change From Baseline in Peak Performance From Incremental Shuttle Walking Test
Hide Description An incremental shuttle walk test is an externally paced maximal exercise test which determined a participant's peak exercise capacity. The maximum duration of the test is 20 minutes. Peak performance was measured in meters, which was defined as the maximum distance covered by a participant until the participant can no longer continue walking during this test. Baseline was defined as the highest non-missing pre-dose assessment from Day -9 and Day 1. Analysis was performed using ANCOVA model. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Highest non-missing pre-dose assessment from Day-9 and Day 1), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 19 18 18 20
Least Squares Mean (Standard Error)
Unit of Measure: Meters
-10.5  (14.76) -17.2  (15.16) -7.5  (15.84) -42.3  (15.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Square Means
Estimated Value -6.7
Confidence Interval (2-Sided) 90%
-42.7 to 29.2
Estimation Comments Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Square Means
Estimated Value -34.8
Confidence Interval (2-Sided) 90%
-72.0 to 2.4
Estimation Comments Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.
37.Secondary Outcome
Title Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 56
Hide Description The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 19 21 21
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-0.8  (0.92) -1.2  (0.97) -0.4  (1.14) -1.0  (1.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 90%
-2.6 to 1.9
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline CAT score, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 90%
-3.4 to 2.1
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline CAT score, with Day as the repeated factor.
38.Secondary Outcome
Title Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Day 90
Hide Description The CAT is a short and simple participant-completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated more severe disease impact. Day 1 (Pre-dose) was considered as a Baseline. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day 1, Pre-dose), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 21 18 18 20
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-1.3  (0.79) -2.2  (0.85) -1.4  (0.94) 0.8  (0.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 90%
-2.9 to 1.1
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline CAT score, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.2
Confidence Interval (2-Sided) 90%
0.0 to 4.5
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and Baseline CAT score, with Day as the repeated factor.
39.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 56
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Time Frame Baseline (Day -9), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 17 12 12 13
Mean (Standard Error)
Unit of Measure: Scores on a Scale
3.7  (1.59) -1.1  (1.80) 1.3  (2.16) -0.8  (2.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.7
Confidence Interval (2-Sided) 90%
-8.9 to -0.6
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.1
Confidence Interval (2-Sided) 90%
-7.2 to 3.1
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.
40.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Difficulty Score at Day 90
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly difficulty score.
Time Frame Baseline (Day -9), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 15 17 13 11
Mean (Standard Error)
Unit of Measure: Scores on a Scale
2.0  (1.90) -2.9  (1.84) 2.8  (2.56) -1.2  (2.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.9
Confidence Interval (2-Sided) 90%
-9.5 to -0.4
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.1
Confidence Interval (2-Sided) 90%
-10.3 to 2.2
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.
41.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 56
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Time Frame Baseline (Day -9), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 17 12 12 13
Mean (Standard Error)
Unit of Measure: Scores on a Scale
3.3  (1.09) 0.2  (1.24) 2.5  (1.83) 2.3  (1.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.1
Confidence Interval (2-Sided) 90%
-5.9 to -0.3
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline amount scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-4.6 to 4.2
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline amount scores, with Day as the repeated factor.
42.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Individual Component: Amount Score at Day 90
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains (amount and difficulty). The 'amount' domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty' domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for 'amount' and 0 to 20 for 'difficulty'. The raw scores were then transformed to a 0 to 100 Rasch analysis based scale for each domain. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented for averaged weekly amount score.
Time Frame Baseline (Day -9), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 15 17 13 11
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-0.2  (2.05) 3.8  (1.98) -0.8  (2.33) 2.7  (2.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.0
Confidence Interval (2-Sided) 90%
-0.8 to 8.8
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline amount scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.5
Confidence Interval (2-Sided) 90%
-2.3 to 9.4
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment*Day and corresponding Baseline amount scores, with Day as the repeated factor.
43.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 56
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented
Time Frame Baseline (Day -9), Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 17 12 12 13
Mean (Standard Error)
Unit of Measure: Scores on a Scale
3.7  (0.89) -0.5  (1.03) 2.1  (1.09) 0.5  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.2
Confidence Interval (2-Sided) 90%
-6.5 to -1.9
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment*Day and corresponding Baseline total scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Confidence Interval (2-Sided) 90%
-4.1 to 1.1
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment*Day and corresponding Baseline total scores, with Day as the repeated factor.
44.Secondary Outcome
Title Change From Baseline in Participant Reported Outcome (PRO)Active Total Score at Day 90
Hide Description The daily PROactive instrument consisted of a PRO questionnaire and an activity monitor to measure participant experience of physical activity. It consisted of 9-item daily assessments covering 2 different domains(amount and difficulty). The'amount'domain was covered by 2 questions combined with 2 activity monitor outputs. The 'difficulty'domain was covered by 5 questions. Individual domains were scored by simple adding items, gave raw score values 0 to 17 for'amount'and 0 to 20 for'difficulty. The raw scores were then transformed to a 0 to 100 Rasch scale for each domain. The 'total score' was obtained by calculating the average between two domains. Total score has the range from 0 to 100. Higher scores indicated worse experience with physical activity. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value. Adjusted means and SE are presented.
Time Frame Baseline (Day -9), Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed.
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 15 17 13 11
Mean (Standard Error)
Unit of Measure: Scores on a Scale
1.3  (1.20) 0.3  (1.14) 1.2  (1.57) 0.5  (1.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo- Female Participants, GSK2881078 1.0 mg- Female Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 90%
-3.8 to 1.8
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment*Day and corresponding Baseline total scores, with Day as the repeated factor.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo- Male Participants, GSK2881078 2.0 mg- Male Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 90%
-4.6 to 3.2
Estimation Comments Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment*Day and corresponding Baseline total scores, with Day as the repeated factor.
45.Secondary Outcome
Title Change From Baseline in Steps Per Day (Physical Activity Measure) as Assessed Via an Accelerometer
Hide Description Steps per day was assessed using an accelerometer, a clinically validated physical activity monitor which was used to measure the levels of physical activity. Participants wore an accelerometer for 7 days during individual timepoint. Values at Baseline, Day 56 and Day 90 were the average values collected from an accelerometer for 7 days after the Day -9, Day 56 and Day 90. Baseline was the average of the data collected from the 7-day period after dispensing of the device on Day -9. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Time Frame Baseline (Day -9), Days 56 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Arm/Group Title Placebo- Female Participants GSK2881078 1.0 mg- Female Participants Placebo- Male Participants GSK2881078 2.0 mg- Male Participants
Hide Arm/Group Description:
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Post-menopausal female participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 0.5 milligram (mg) once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 matching placebo once daily over 13 weeks.
Male participants, 50 to 75 years of age, were administered orally two capsules of GSK2881078 of a unit dose strength 1.0 mg once daily over 13 weeks.
Overall Number of Participants Analyzed 17 17 14 17
Mean (Standard Deviation)
Unit of Measure: Steps per day
Day 56,n=17,14,14,17 Number Analyzed 17 participants 14 participants 14 participants 17 participants
285.19  (1289.604) 389.58  (1322.701) 120.41  (1282.092) -17.40  (1334.539)
Day 90,n=17,17,14,14 Number Analyzed 17 participants 17 participants 14 participants 14 participants
-246.45  (756.414) 786.21  (1439.988) -527.07  (1077.747) 611.36  (1499.559)