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Trial record 7 of 7 for:    LY2886721

Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

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: NCT01561430
Recruitment Status : Terminated (Study terminated due to abnormal liver biochemical tests in some participants.)
First Posted : March 23, 2012
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
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: Basic Science
Condition Alzheimer's Disease
Interventions Drug: LY2886721
Drug: Placebo
Enrollment 70

Recruitment Details  
Pre-assignment Details As a result of findings from the I4O-MC-BACJ study (NCT01534273), enrollment was discontinued to the 15 milligrams (mg) arm. The 9 participants already enrolled were allowed to continue study treatment at the 15 mg dose.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks. LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks. LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks. Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Period Title: Overall Study
Started 9 23 18 20
Received at Least One Dose of Study Drug 9 23 18 20
Completed 8 8 1 7
Not Completed 1 15 17 13
Reason Not Completed
Adverse Event             0             0             3             1
Withdrawal by Subject             0             0             1             0
Physician Decision             0             1             0             0
Sponsor Decision             1             14             13             12
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo Total
Hide Arm/Group Description LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks. LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks. LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks. Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 9 23 18 20 70
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 23 participants 18 participants 20 participants 70 participants
65.59  (7.569) 72.50  (8.378) 70.23  (8.603) 67.73  (7.126) 69.66  (8.201)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 23 participants 18 participants 20 participants 70 participants
Female
5
  55.6%
10
  43.5%
7
  38.9%
11
  55.0%
33
  47.1%
Male
4
  44.4%
13
  56.5%
11
  61.1%
9
  45.0%
37
  52.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 23 participants 18 participants 20 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
  13.0%
3
  16.7%
0
   0.0%
6
   8.6%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
9
 100.0%
20
  87.0%
15
  83.3%
20
 100.0%
64
  91.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 23 participants 18 participants 20 participants 70 participants
United States
8
  88.9%
19
  82.6%
15
  83.3%
18
  90.0%
60
  85.7%
Netherlands
1
  11.1%
1
   4.3%
1
   5.6%
2
  10.0%
5
   7.1%
Japan
0
   0.0%
3
  13.0%
2
  11.1%
0
   0.0%
5
   7.1%
1.Primary Outcome
Title Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Hide Description Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.
Time Frame Baseline, 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 7 9 5 12
Least Squares Mean (Standard Error)
Unit of Measure: percent change in Aβ1-40 and Aβ1-42
Aβ1-40 Number Analyzed 7 participants 9 participants 5 participants 11 participants
-31.8  (7.35) -57.7  (6.67) -58.9  (8.73) 3.7  (5.96)
Aβ1-42 Number Analyzed 7 participants 9 participants 5 participants 12 participants
-34.4  (7.27) -52.0  (6.80) -60.7  (8.42) 6.5  (6.06)
2.Primary Outcome
Title Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations
Hide Description Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 26 weeks post-dose was to be calculated. The units for CSF were picograms per milliliter (pg/mL). LS means of percent change in concentration from baseline was calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. CSF Aβ1-40 and Aβ1-42 concentrations data was not collected for analysis at 26 weeks.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Hide Description Percent change in plasma concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL).
Time Frame Baseline, 12 weeks, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 6 8 4 12
Mean (Standard Deviation)
Unit of Measure: percent change in Aβ1-40 and Aβ1-42
Aβ1-40, Week 12 Number Analyzed 6 participants 8 participants 4 participants 12 participants
-73.4  (6.22) -80.8  (8.07) -88.1  (2.66) 1.90  (15.0)
Aβ1-40, Week 26 Number Analyzed 5 participants 6 participants 1 participants 6 participants
-72.3  (11.5) -85.0  (3.89) -89.1 [1]   (NA) 0.944  (22.6)
Aβ1-42, Week 12 Number Analyzed 6 participants 8 participants 4 participants 12 participants
-63.4  (6.11) -71.1  (8.38) -78.2  (5.08) 0.541  (10.1)
Aβ1-42, Week 26 Number Analyzed 5 participants 6 participants 1 participants 6 participants
-65.1  (8.85) -75.0  (4.33) -80.8 [1]   (NA) 1.82  (9.98)
[1]
Standard deviation not reported due to not enough participants for analyses.
4.Secondary Outcome
Title Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)
Hide Description The NTB is a composite cognitive measure in clinical Alzheimer’s disease studies and is a collection of several written and oral tests that examines verbal and nonverbal brain functions. NTB Z-score typically ranges from -3 to 3, with lower scores suggesting greater cognitive impairment. LS means were calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable NTB data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 8 7 1 9
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.039  (0.1096) -0.161  (0.1165) 0.424  (0.3156) -0.262  (0.1028)
5.Secondary Outcome
Title Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Hide Description ADAS-Cog11 is an 11-item instrument measuring impairment in memory (Items 1-4, 7, 11), praxis (Items 4 and 5), orientation (Item 6), and language (Items 8-10). Item 1 ranged 0 (all items recalled correctly)-10 (none recalled correctly); Items 2-5 and 8-11 ranged 0 (all items named, performed, drawn, spoken, remember correctly/clearly)-5 (none correct/not clearly spoken); Item 6 ranged 0 (no incorrect responses)-8 (all incorrect); and Item 7 ranged 0 (all words remembered correctly)-12 (no words remembered correctly) for a total ADAS-Cog11 score of 0-70 with higher scores indicating greater disease severity. A score of 0-10 for delayed free recall and a conversion code of 0-5 for digit cancellation and maze completion was added to the total ADAS-Cog11 score for a total ADAS‑Cog14 score ranging 0-90 with higher scores indicating greater impairment. LS means were calculated using Mixed Model Repeated Measures (MMRM) with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable ADAS-Cog data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 7 9 1 9
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.1  (2.77) 0.6  (2.48) 0.6  (7.41) 1.3  (2.44)
6.Secondary Outcome
Title Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Hide Description The CDR-SB is a composite measure of 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores ranged from 0 to 18, with higher scores indicating greater impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable CDR-SB data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 8 9 1 8
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.80  (0.432) 0.52  (0.395) 1.50  (1.013) 1.19  (0.402)
7.Secondary Outcome
Title Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)
Hide Description The MMSE (Folstein et al. 1975) is one of the most widely used screening instruments for cognitive impairment. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and provides a total score ranging from 0 to 30, with lower scores indicative of greater cognitive impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable MMSE data.
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 8 9 1 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.7  (0.87) -1.8  (0.81) 0.2  (2.41) -3.0  (0.77)
8.Secondary Outcome
Title Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations
Hide Description Percent change in lumbar CSF tau and ptau-181 concentrations from baseline at 12 weeks post-dose and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.
Time Frame Baseline, 12 weeks, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

All randomized participants at 12 weeks with evaluable post-baseline CSF Tau or Ptau data.

Zero participants analyzed for 26 week CSF Tau or Ptau as data was not collected for analysis.

Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description:
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Overall Number of Participants Analyzed 7 9 5 12
Least Squares Mean (Standard Error)
Unit of Measure: percent change in tau and ptau-181
CSF Tau, Week 12 Number Analyzed 7 participants 9 participants 5 participants 12 participants
14.3  (6.06) 2.6  (5.42) 6.8  (7.49) -4.4  (4.63)
CSF Tau, Week 26 Number Analyzed 0 participants 0 participants 0 participants 0 participants
CSF Ptau, Week 12 Number Analyzed 7 participants 9 participants 5 participants 12 participants
0.7  (4.81) 1.7  (4.01) 4.3  (5.41) -3.6  (3.40)
CSF Ptau, Week 26 Number Analyzed 0 participants 0 participants 0 participants 0 participants
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Hide Arm/Group Description LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks. LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks. LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks. Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
All-Cause Mortality
15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      2/23 (8.70%)      0/18 (0.00%)      0/20 (0.00%)    
Gastrointestinal disorders         
Crohn's disease  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Small intestinal obstruction  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders         
Syncope  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
15 mg LY2886721 35 mg LY2886721 70 mg LY2886721 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/9 (88.89%)      13/23 (56.52%)      16/18 (88.89%)      15/20 (75.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Leukocytosis  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Bradycardia  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Ear and labyrinth disorders         
Vertigo  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Endocrine disorders         
Hypothyroidism  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Eye disorders         
Cataract nuclear  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Diplopia  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Eye irritation  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Lacrimation increased  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Visual acuity reduced  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  0/9 (0.00%)  0 1/23 (4.35%)  2 0/18 (0.00%)  0 0/20 (0.00%)  0
Abdominal distension  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Abdominal pain upper  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Abdominal tenderness  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Dental caries  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Diarrhoea  1  0/9 (0.00%)  0 1/23 (4.35%)  1 1/18 (5.56%)  1 1/20 (5.00%)  1
Diverticulum intestinal  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  2
Dry mouth  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Flatulence  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Gastritis erosive  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorder  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  2
Gastrooesophageal reflux disease  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Haematochezia  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Haemorrhoidal haemorrhage  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Haemorrhoids  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Hiatus hernia  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Lip swelling  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Nausea  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Oesophageal disorder  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Oesophagitis  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Small intestinal obstruction  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Vomiting  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
General disorders         
Asthenia  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Fatigue  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Oedema peripheral  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Pyrexia  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Thirst  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Hepatobiliary disorders         
Hepatic function abnormal  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Infections and infestations         
Herpes zoster  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Nasopharyngitis  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Sinusitis  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Upper respiratory tract infection  1  1/9 (11.11%)  1 1/23 (4.35%)  1 1/18 (5.56%)  1 1/20 (5.00%)  1
Urinary tract infection  1  1/9 (11.11%)  1 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications         
Accidental overdose  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Alcohol poisoning  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Contusion  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Fall  1  0/9 (0.00%)  0 1/23 (4.35%)  1 2/18 (11.11%)  3 1/20 (5.00%)  1
Feeding tube complication  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Foot fracture  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Joint injury  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Laceration  1  0/9 (0.00%)  0 0/23 (0.00%)  0 2/18 (11.11%)  3 1/20 (5.00%)  1
Tooth fracture  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Amylase increased  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Blood alkaline phosphatase increased  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Blood creatine phosphokinase increased  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 2/20 (10.00%)  2
Blood pressure increased  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Colour vision tests abnormal red-green  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Electrocardiogram change  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/9 (11.11%)  1 0/23 (0.00%)  0 3/18 (16.67%)  3 0/20 (0.00%)  0
Lipase increased  1  0/9 (0.00%)  0 1/23 (4.35%)  1 1/18 (5.56%)  2 0/20 (0.00%)  0
Liver function test abnormal  1  1/9 (11.11%)  1 2/23 (8.70%)  2 1/18 (5.56%)  1 0/20 (0.00%)  0
Weight increased  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Dehydration  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Hypokalaemia  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Increased appetite  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Back pain  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  2 1/20 (5.00%)  1
Joint range of motion decreased  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Joint swelling  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Muscle spasms  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 2/20 (10.00%)  2
Muscle tightness  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Musculoskeletal chest pain  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  2
Musculoskeletal stiffness  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Squamous cell carcinoma of skin  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders         
Apraxia  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Balance disorder  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Cerebral microhaemorrhage  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Decreased vibratory sense  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Dizziness  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Dysgeusia  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Headache  1  2/9 (22.22%)  2 1/23 (4.35%)  1 1/18 (5.56%)  1 0/20 (0.00%)  0
Sinus headache  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  4 0/20 (0.00%)  0
Psychiatric disorders         
Abnormal dreams  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Agitation  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Anxiety  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Confusional state  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 1/20 (5.00%)  1
Delusion  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 1/20 (5.00%)  1
Depression  1  0/9 (0.00%)  0 0/23 (0.00%)  0 3/18 (16.67%)  3 0/20 (0.00%)  0
Disorientation  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Hallucination  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Hallucination, visual  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Hypnopompic hallucination  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Initial insomnia  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Insomnia  1  1/9 (11.11%)  1 1/23 (4.35%)  2 0/18 (0.00%)  0 1/20 (5.00%)  1
Nightmare  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Obsessive thoughts  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Parasomnia  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Restlessness  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Sleep talking  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Stereotypy  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Terminal insomnia  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Renal and urinary disorders         
Cystitis interstitial  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Pollakiuria  1  1/9 (11.11%)  1 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Renal failure chronic  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders         
Actinic keratosis  1  1/9 (11.11%)  2 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Eczema  1  0/9 (0.00%)  0 1/23 (4.35%)  1 0/18 (0.00%)  0 0/20 (0.00%)  0
Rash  1  0/9 (0.00%)  0 0/23 (0.00%)  0 1/18 (5.56%)  1 0/20 (0.00%)  0
Rash macular  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Rash vesicular  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Urticaria  1  0/9 (0.00%)  0 0/23 (0.00%)  0 0/18 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders         
Hypertension  1  1/9 (11.11%)  1 0/23 (0.00%)  0 0/18 (0.00%)  0 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Study was terminated early because of abnormal liver biochemical tests levels for 4 participants.
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.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01561430     History of Changes
Other Study ID Numbers: 13735
I4O-MC-BACC ( Other Identifier: Eli Lilly and Company )
2011-005217-37 ( EudraCT Number )
First Submitted: March 21, 2012
First Posted: March 23, 2012
Results First Submitted: March 24, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018