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A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia

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: NCT02972658
Recruitment Status : Terminated (An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.)
First Posted : November 23, 2016
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Drug: Lanabecestat
Enrollment 421
Recruitment Details Participants who completed feeder study [AZES (NCT02245737)] were enrolled in this study.
Pre-assignment Details Participants who were randomized in Study AZES to either 20 milligrams (mg) or 50 mg of lanabecestat continued on the treatment allocation from the feeder study. Participants randomized to placebo in Study AZES were randomized in a blinded fashion, 1:1 ratio, to either lanabecestat 20 mg or 50 mg daily (QD), administered orally.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg. Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg. Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg. Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
Period Title: Overall Study
Started 76 139 75 131
Received at Least 1 Dose of Study Drug 76 139 74 131
Completed 0 1 [1] 0 0
Not Completed 76 138 75 131
Reason Not Completed
Adverse Event             0             3             0             2
Other-determined by Investigator             1             1             0             0
Death             0             0             0             1
Lost to Follow-up             0             1             1             2
Progressive Disease             0             1             0             1
Withdrawal by Subject             4             4             1             6
Withdrawal due to Caregiver Circumstance             1             1             1             0
Sponsor Decision             70             127             72             119
[1]
1 participant was incorrectly marked as “Completed” rather than study terminated by Sponsor.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg Total
Hide Arm/Group Description Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg. Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg. Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg. Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg. Total of all reporting groups
Overall Number of Baseline Participants 76 139 75 131 421
Hide Baseline Analysis Population Description
All randomized participants who received study drug.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
70.7  (6.6) 69.8  (7.8) 71.1  (6.6) 70.1  (6.7) 70.3  (7.0)
[1]
Measure Description: Details are from AZES baseline.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
Female 35 76 40 75 226
Male 41 63 35 56 195
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
Hispanic or Latino 7 4 4 3 18
Not Hispanic or Latino 62 115 54 114 345
Unknown or Not Reported 7 20 17 14 58
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
American Indian or Alaska Native 0 0 0 0 0
Asian 7 23 10 16 56
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 2 1 0 3
White 64 104 51 106 325
More than one race 0 0 0 0 0
Unknown or Not Reported 5 10 13 9 37
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
Puerto Rico 0 1 0 0 1
Romania 1 1 0 0 2
Hungary 1 0 0 0 1
United States 23 35 13 23 94
Japan 6 14 5 14 39
United Kingdom 8 17 8 13 46
Spain 10 21 8 21 60
Canada 6 8 5 14 33
South Korea 1 7 3 2 13
Belgium 5 2 0 4 11
Poland 6 8 6 14 34
France 4 9 12 8 33
Australia 3 13 8 6 30
Germany 2 3 7 12 24
ADAS-Cog13 (13-item Alzheimer’s Disease Assessment Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 76 participants 139 participants 75 participants 131 participants 421 participants
27.9  (8.3) 29.6  (7.8) 27.0  (7.5) 27.1  (7.5) 27.9  (7.8)
[1]
Measure Description: ADAS-Cog13, a 13-item rating scale, measured the severity of cognitive dysfunction in persons with Alzheimer's disease (AD). Scores ranged from 0 to 85, with a higher score indicating worse cognitive functioning. Details are from AZES baseline.
1.Primary Outcome
Title Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Hide Description ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure. Feeder study AZES was stopped for futility, the original Delayed Start analysis was replaced with MMRM analysis and no comparisons between treatment groups were made.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 139 75 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.61  (1.60) 9.25  (1.21) 8.41  (1.65) 10.41  (1.25)
2.Secondary Outcome
Title Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
Hide Description The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 139 74 129
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-9.19  (1.47) -8.45  (1.10) -7.37  (1.51) -7.48  (1.14)
3.Secondary Outcome
Title Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
Hide Description FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 137 74 130
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.28  (0.98) 7.09  (0.76) 6.73  (1.01) 6.91  (0.79)
4.Secondary Outcome
Title Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Hide Description The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 138 72 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-18.85  (2.58) -17.57  (1.97) -15.37  (2.76) -18.37  (2.09)
5.Secondary Outcome
Title Change From Baseline on the Mini-Mental Status Examination (MMSE)
Hide Description The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 139 75 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.84  (0.71) -5.73  (0.54) -4.72  (0.72) -5.25  (0.56)
6.Secondary Outcome
Title Change From Baseline Analysis on the ADAS-Cog13
Hide Description ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
Time Frame AZES Baseline through AZFD Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description:
Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.
Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
Overall Number of Participants Analyzed 76 139 75 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
16.64  (3.45) 12.40  (2.25) 16.79  (2.47) 15.05  (2.06)
Time Frame Up To 156 Weeks
Adverse Event Reporting Description All AZFD participants who received at least one dose of study drug.
 
Arm/Group Title AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Hide Arm/Group Description Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD. Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD. Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD. Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.
All-Cause Mortality
AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/76 (0.00%)      0/139 (0.00%)      0/74 (0.00%)      1/131 (0.76%)    
Show Serious Adverse Events Hide Serious Adverse Events
AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/76 (3.95%)      8/139 (5.76%)      5/74 (6.76%)      7/131 (5.34%)    
Cardiac disorders         
Bradycardia  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Gastrointestinal disorders         
Colitis  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Enteritis  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Oesophageal motility disorder  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Small intestinal obstruction  1  0/76 (0.00%)  0 0/139 (0.00%)  0 1/74 (1.35%)  1 0/131 (0.00%)  0
Infections and infestations         
Diverticulitis  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Influenza  1  0/76 (0.00%)  0 0/139 (0.00%)  0 1/74 (1.35%)  1 0/131 (0.00%)  0
Pneumonia  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Injury, poisoning and procedural complications         
Fall  1  1/76 (1.32%)  1 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Femoral neck fracture  1  1/76 (1.32%)  1 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Femur fracture  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Radiation proctitis  1  0/76 (0.00%)  0 0/139 (0.00%)  0 1/74 (1.35%)  1 0/131 (0.00%)  0
Investigations         
Electrocardiogram repolarisation abnormality  1  0/76 (0.00%)  0 0/139 (0.00%)  0 1/74 (1.35%)  1 0/131 (0.00%)  0
Weight decreased  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Musculoskeletal chest pain  1  0/76 (0.00%)  0 0/139 (0.00%)  0 0/74 (0.00%)  0 1/131 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer in situ  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Breast cancer metastatic  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Laryngeal squamous cell carcinoma  1  1/76 (1.32%)  1 0/139 (0.00%)  0 0/74 (0.00%)  0 0/131 (0.00%)  0
Nervous system disorders         
Ischaemic stroke  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Optic neuritis  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Psychiatric disorders         
Depression  1  0/76 (0.00%)  0 1/139 (0.72%)  1 0/74 (0.00%)  0 0/131 (0.00%)  0
Neuropsychiatric symptoms  1  0/76 (0.00%)  0 0/139 (0.00%)  0 1/74 (1.35%)  1 1/131 (0.76%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZES Placebo/AZFD Lanabecestat 20 mg AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg AZES Placebo/AZFD Lanabecestat 50 mg AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/76 (14.47%)      23/139 (16.55%)      8/74 (10.81%)      17/131 (12.98%)    
Gastrointestinal disorders         
Diarrhoea  1  2/76 (2.63%)  2 8/139 (5.76%)  8 2/74 (2.70%)  2 6/131 (4.58%)  6
Infections and infestations         
Nasopharyngitis  1  1/76 (1.32%)  1 8/139 (5.76%)  10 3/74 (4.05%)  3 5/131 (3.82%)  7
Injury, poisoning and procedural complications         
Fall  1  4/76 (5.26%)  4 7/139 (5.04%)  8 3/74 (4.05%)  3 5/131 (3.82%)  8
Psychiatric disorders         
Depression  1  4/76 (5.26%)  4 3/139 (2.16%)  3 0/74 (0.00%)  0 2/131 (1.53%)  2
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility. Because of this futility, the originally planned delayed-start analysis was not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor shall review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Investigator shall delay publication of their results of the study until the results of the multi-center study are published or presented, provided the multi-center results are published within 24 months of the termination.
Results Point of Contact
Name/Title: AstraZeneca Information Center
Organization: AstraZeneca
Phone: 877-240-9479
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02972658     History of Changes
Other Study ID Numbers: 16557
I8D-MC-AZFD ( Other Identifier: Eli Lilly and Company )
2016-003440-36 ( EudraCT Number )
First Submitted: November 21, 2016
First Posted: November 23, 2016
Results First Submitted: June 11, 2019
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019