Trial Outcomes & Findings for Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease (NCT NCT01561430)
NCT ID: NCT01561430
Last Updated: 2018-05-18
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2018-05-18
Participant Flow
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.
Participant milestones
| Measure |
15 mg LY2886721
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
23
|
18
|
20
|
|
Overall Study
Received at Least One Dose of Study Drug
|
9
|
23
|
18
|
20
|
|
Overall Study
COMPLETED
|
8
|
8
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
15
|
17
|
13
|
Reasons for withdrawal
| Measure |
15 mg LY2886721
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
14
|
13
|
12
|
Baseline Characteristics
Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
15 mg LY2886721
n=9 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=23 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=18 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=20 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.59 years
STANDARD_DEVIATION 7.569 • n=5 Participants
|
72.50 years
STANDARD_DEVIATION 8.378 • n=7 Participants
|
70.23 years
STANDARD_DEVIATION 8.603 • n=5 Participants
|
67.73 years
STANDARD_DEVIATION 7.126 • n=4 Participants
|
69.66 years
STANDARD_DEVIATION 8.201 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=7 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=9 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=5 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=12 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-40
|
-31.8 percent change in Aβ1-40 and Aβ1-42
Standard Error 7.35
|
-57.7 percent change in Aβ1-40 and Aβ1-42
Standard Error 6.67
|
-58.9 percent change in Aβ1-40 and Aβ1-42
Standard Error 8.73
|
3.7 percent change in Aβ1-40 and Aβ1-42
Standard Error 5.96
|
|
Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-42
|
-34.4 percent change in Aβ1-40 and Aβ1-42
Standard Error 7.27
|
-52.0 percent change in Aβ1-40 and Aβ1-42
Standard Error 6.80
|
-60.7 percent change in Aβ1-40 and Aβ1-42
Standard Error 8.42
|
6.5 percent change in Aβ1-40 and Aβ1-42
Standard Error 6.06
|
PRIMARY outcome
Timeframe: Baseline, 26 weeksPopulation: Zero participants analyzed. CSF Aβ1-40 and Aβ1-42 concentrations data was not collected for analysis at 26 weeks.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 26 weeksPopulation: All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.
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).
Outcome measures
| Measure |
15 mg LY2886721
n=6 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=8 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=4 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=12 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-40, Week 12
|
-73.4 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 6.22
|
-80.8 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 8.07
|
-88.1 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 2.66
|
1.90 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 15.0
|
|
Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-40, Week 26
|
-72.3 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 11.5
|
-85.0 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 3.89
|
-89.1 percent change in Aβ1-40 and Aβ1-42
Standard Deviation NA
Standard deviation not reported due to not enough participants for analyses.
|
0.944 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 22.6
|
|
Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-42, Week 12
|
-63.4 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 6.11
|
-71.1 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 8.38
|
-78.2 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 5.08
|
0.541 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 10.1
|
|
Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations
Aβ1-42, Week 26
|
-65.1 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 8.85
|
-75.0 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 4.33
|
-80.8 percent change in Aβ1-40 and Aβ1-42
Standard Deviation NA
Standard deviation not reported due to not enough participants for analyses.
|
1.82 percent change in Aβ1-40 and Aβ1-42
Standard Deviation 9.98
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants with evaluable NTB data.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=8 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=7 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=1 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=9 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)
|
-0.039 units on a scale
Standard Error 0.1096
|
-0.161 units on a scale
Standard Error 0.1165
|
0.424 units on a scale
Standard Error 0.3156
|
-0.262 units on a scale
Standard Error 0.1028
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants with evaluable ADAS-Cog data.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=7 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=9 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=1 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=9 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
|
1.1 units on a scale
Standard Error 2.77
|
0.6 units on a scale
Standard Error 2.48
|
0.6 units on a scale
Standard Error 7.41
|
1.3 units on a scale
Standard Error 2.44
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants with evaluable CDR-SB data.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=8 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=9 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=1 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=8 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
|
0.80 units on a scale
Standard Error 0.432
|
0.52 units on a scale
Standard Error 0.395
|
1.50 units on a scale
Standard Error 1.013
|
1.19 units on a scale
Standard Error 0.402
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: All randomized participants with evaluable MMSE data.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=8 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=9 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=1 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=10 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)
|
-0.7 units on a scale
Standard Error 0.87
|
-1.8 units on a scale
Standard Error 0.81
|
0.2 units on a scale
Standard Error 2.41
|
-3.0 units on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
15 mg LY2886721
n=7 Participants
LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=9 Participants
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=5 Participants
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=12 Participants
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations
CSF Tau, Week 12
|
14.3 percent change in tau and ptau-181
Standard Error 6.06
|
2.6 percent change in tau and ptau-181
Standard Error 5.42
|
6.8 percent change in tau and ptau-181
Standard Error 7.49
|
-4.4 percent change in tau and ptau-181
Standard Error 4.63
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations
CSF Ptau, Week 12
|
0.7 percent change in tau and ptau-181
Standard Error 4.81
|
1.7 percent change in tau and ptau-181
Standard Error 4.01
|
4.3 percent change in tau and ptau-181
Standard Error 5.41
|
-3.6 percent change in tau and ptau-181
Standard Error 3.40
|
Adverse Events
15 mg LY2886721
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
35 mg LY2886721
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
70 mg LY2886721
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15 mg LY2886721
n=9 participants at risk
LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=23 participants at risk
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=18 participants at risk
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=20 participants at risk
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Nervous system disorders
Syncope
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
Other adverse events
| Measure |
15 mg LY2886721
n=9 participants at risk
LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks.
|
35 mg LY2886721
n=23 participants at risk
LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
|
70 mg LY2886721
n=18 participants at risk
LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
|
Placebo
n=20 participants at risk
Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Eye disorders
Eye irritation
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9
|
4.3%
1/23 • Number of events 2
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Asthenia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
General disorders
Fatigue
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
General disorders
Oedema peripheral
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
General disorders
Thirst
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
11.1%
2/18 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/9
|
0.00%
0/23
|
11.1%
2/18 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Amylase increased
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood pressure increased
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Investigations
Colour vision tests abnormal red-green
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Electrocardiogram change
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
16.7%
3/18 • Number of events 3
|
0.00%
0/20
|
|
Investigations
Lipase increased
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
5.6%
1/18 • Number of events 2
|
0.00%
0/20
|
|
Investigations
Liver function test abnormal
|
11.1%
1/9 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Weight increased
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Nervous system disorders
Apraxia
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 4
|
0.00%
0/20
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Delusion
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/9
|
0.00%
0/23
|
16.7%
3/18 • Number of events 3
|
0.00%
0/20
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Hypnopompic hallucination
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1
|
4.3%
1/23 • Number of events 2
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Nightmare
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Psychiatric disorders
Obsessive thoughts
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Psychiatric disorders
Sleep talking
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Psychiatric disorders
Stereotypy
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Psychiatric disorders
Terminal insomnia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
Pollakiuria
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
11.1%
1/9 • Number of events 2
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/9
|
4.3%
1/23 • Number of events 1
|
0.00%
0/18
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9
|
0.00%
0/23
|
5.6%
1/18 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9
|
0.00%
0/23
|
0.00%
0/18
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1
|
0.00%
0/23
|
0.00%
0/18
|
0.00%
0/20
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60