Trial Outcomes & Findings for A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes (NCT NCT02020616)
NCT ID: NCT02020616
Last Updated: 2019-10-08
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2019-10-08
Participant Flow
The study was planned in 2 stages; Stage 1 evaluated up to 5 escalating parallel-dose groups. Stage 2, which was to evaluate participants stratified by Hemoglobin A1c (HbA1c), metformin therapy, and washout of a second oral anti-hyperglycemic medication (OAM) was not conducted because of inadequate efficacy at well-tolerated doses in Stage 1.
Participant milestones
| Measure |
Placebo
Placebo administered by subcutaneous injection (SC) once a week (Q1W) for 12 weeks
|
7 mg LY3053102
7 mg LY3053102 administered SC Q1W for 12 weeks.
|
15 mg LY3053102
15 mg LY3053102 administered SC Q1W for 12 weeks.
|
50 mg LY3053102
50 mg LY3053102 administered SC Q1W for 12 weeks.
|
100 mg LY3053102
100 mg LY3053102 administered SC Q1W for 12 weeks.
|
200 mg LY3053102
200 mg LY3053102 administered SC Q1W for 12 weeks.
|
2 mg Exenatide ER
2 mg exenatide ER administered SC Q1W for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
8
|
8
|
8
|
8
|
10
|
|
Overall Study
Received at Least One Dose of Study Drug
|
10
|
8
|
8
|
7
|
8
|
8
|
10
|
|
Overall Study
COMPLETED
|
10
|
7
|
6
|
6
|
6
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
2
|
2
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered by subcutaneous injection (SC) once a week (Q1W) for 12 weeks
|
7 mg LY3053102
7 mg LY3053102 administered SC Q1W for 12 weeks.
|
15 mg LY3053102
15 mg LY3053102 administered SC Q1W for 12 weeks.
|
50 mg LY3053102
50 mg LY3053102 administered SC Q1W for 12 weeks.
|
100 mg LY3053102
100 mg LY3053102 administered SC Q1W for 12 weeks.
|
200 mg LY3053102
200 mg LY3053102 administered SC Q1W for 12 weeks.
|
2 mg Exenatide ER
2 mg exenatide ER administered SC Q1W for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Early Termination Criteria Met
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized in Error
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC QW for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC QW for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 administered SC QW for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC QW for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC QW for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg Exenatide ER administered SC QW for 12 weeks
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.9 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
57.3 Years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
50.8 Years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
54.6 Years
STANDARD_DEVIATION 8.3 • n=8 Participants
|
52.8 Years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
55.3 Years
STANDARD_DEVIATION 8.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
44 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
|
Baseline Hemoglobin A1c (HbA1c)
|
8.39 Percent of HbA1c
STANDARD_DEVIATION 0.80 • n=5 Participants
|
8.33 Percent of HbA1c
STANDARD_DEVIATION 1.17 • n=7 Participants
|
7.93 Percent of HbA1c
STANDARD_DEVIATION 0.81 • n=5 Participants
|
8.30 Percent of HbA1c
STANDARD_DEVIATION 0.74 • n=4 Participants
|
9.40 Percent of HbA1c
STANDARD_DEVIATION 1.43 • n=21 Participants
|
8.10 Percent of HbA1c
STANDARD_DEVIATION 0.63 • n=8 Participants
|
8.50 Percent of HbA1c
STANDARD_DEVIATION 1.03 • n=8 Participants
|
8.42 Percent of HbA1c
STANDARD_DEVIATION 1.02 • n=24 Participants
|
|
Baseline Fasting Plasma Glucose
|
180.6 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 45.3 • n=5 Participants
|
178.6 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 44.3 • n=7 Participants
|
176.6 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 58.0 • n=5 Participants
|
173.3 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 39.6 • n=4 Participants
|
183.3 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 46.2 • n=21 Participants
|
185.9 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 50.6 • n=8 Participants
|
150.6 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 46.8 • n=8 Participants
|
174.9 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 46.5 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.
Outcome measures
| Measure |
7 mg LY3053102
n=7 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=5 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=5 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=7 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=3 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=6 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint
|
-0.70 Percent of HbA1c
Standard Error 0.40
|
-0.75 Percent of HbA1c
Standard Error 0.44
|
-0.22 Percent of HbA1c
Standard Error 0.43
|
-0.48 Percent of HbA1c
Standard Error 0.40
|
-0.52 Percent of HbA1c
Standard Error 0.47
|
-1.43 Percent of HbA1c
Standard Error 0.36
|
-0.49 Percent of HbA1c
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint
HbA1c <7.0%
|
14.3 Percentage of Participants
|
40.0 Percentage of Participants
|
20.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
83.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint
HbA1c ≤6.5%
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
66.7 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who took at least 1 dose of study drug, and who had a baseline and a post-baseline measurement for the time point.
Percentage of participants that required \>=1 rescue (blood glucose lowering) medications.
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants That Require Rescue Therapy
|
0.0 Percentage of Participants
|
12.5 Percentage of Participants
|
14.3 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=7 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=5 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=5 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=7 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=4 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=7 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at 12-Week Endpoint
|
1.5 kilogram (kg)
Standard Error 1.3
|
0.0 kilogram (kg)
Standard Error 1.4
|
0.4 kilogram (kg)
Standard Error 1.4
|
-1.7 kilogram (kg)
Standard Error 1.3
|
-2.0 kilogram (kg)
Standard Error 1.4
|
-0.1 kilogram (kg)
Standard Error 1.1
|
0.7 kilogram (kg)
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=7 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=5 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=5 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=7 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=3 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=5 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint
Morning Meal (Post- minus Pre-prandial)
|
-18.7 milligram/deciliter (mg/dL)
Standard Error 19.4
|
-57.7 milligram/deciliter (mg/dL)
Standard Error 21.6
|
-34.9 milligram/deciliter (mg/dL)
Standard Error 21.9
|
4.7 milligram/deciliter (mg/dL)
Standard Error 18.3
|
-26.8 milligram/deciliter (mg/dL)
Standard Error 25.8
|
-47.9 milligram/deciliter (mg/dL)
Standard Error 19.4
|
-23.4 milligram/deciliter (mg/dL)
Standard Error 15.8
|
|
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint
Midday Meal (Post- minus Pre-prandial)
|
-31.3 milligram/deciliter (mg/dL)
Standard Error 27.5
|
-55.0 milligram/deciliter (mg/dL)
Standard Error 29.2
|
-24.7 milligram/deciliter (mg/dL)
Standard Error 29.2
|
2.5 milligram/deciliter (mg/dL)
Standard Error 25.8
|
-24.6 milligram/deciliter (mg/dL)
Standard Error 32.3
|
-31.3 milligram/deciliter (mg/dL)
Standard Error 24.9
|
-1.1 milligram/deciliter (mg/dL)
Standard Error 22.4
|
|
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint
Evening Meal (Post- minus Pre-prandial)
|
-11.1 milligram/deciliter (mg/dL)
Standard Error 25.8
|
-46.5 milligram/deciliter (mg/dL)
Standard Error 27.5
|
-25.9 milligram/deciliter (mg/dL)
Standard Error 27.9
|
-39.0 milligram/deciliter (mg/dL)
Standard Error 24.1
|
-61.3 milligram/deciliter (mg/dL)
Standard Error 31.4
|
-4.9 milligram/deciliter (mg/dL)
Standard Error 24.2
|
-18.8 milligram/deciliter (mg/dL)
Standard Error 20.8
|
|
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint
Bedtime
|
18.8 milligram/deciliter (mg/dL)
Standard Error 23.3
|
-44.5 milligram/deciliter (mg/dL)
Standard Error 28.1
|
-10.1 milligram/deciliter (mg/dL)
Standard Error 25.7
|
4.9 milligram/deciliter (mg/dL)
Standard Error 22.1
|
-13.0 milligram/deciliter (mg/dL)
Standard Error 30.8
|
-53.6 milligram/deciliter (mg/dL)
Standard Error 23.5
|
3.9 milligram/deciliter (mg/dL)
Standard Error 19.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Lipids at 12-Week Endpoint
HDL-C
|
6.0 mg/dL
Standard Error 2.6
|
9.3 mg/dL
Standard Error 2.9
|
6.4 mg/dL
Standard Error 2.9
|
6.0 mg/dL
Standard Error 2.6
|
11.4 mg/dL
Standard Error 3.1
|
-2.3 mg/dL
Standard Error 2.2
|
1.0 mg/dL
Standard Error 2.2
|
|
Change From Baseline in Lipids at 12-Week Endpoint
LDL-C
|
6.8 mg/dL
Standard Error 12.0
|
-25.6 mg/dL
Standard Error 13.8
|
-6.5 mg/dL
Standard Error 13.5
|
-2.2 mg/dL
Standard Error 12.0
|
-7.3 mg/dL
Standard Error 14.5
|
-19.9 mg/dL
Standard Error 11.3
|
12.1 mg/dL
Standard Error 10.4
|
SECONDARY outcome
Timeframe: Baseline through Study Completion (Up to 6 Months)Population: All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity.
Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies to LY3053102
|
1 Percentage of Participants
|
1 Percentage of Participants
|
0 Percentage of Participants
|
2 Percentage of Participants
|
2 Percentage of Participants
|
2 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All randomized participants who received at least 1 dose of study drug.
Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Hypoglycemia
|
12.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
12.5 Percentage of Participants
|
12.5 Percentage of Participants
|
20.0 Percentage of Participants
|
10.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug.
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])
Osteocalcin
|
-0.7 microgram/liter (ug/L)
Standard Error 1.3
|
-1.7 microgram/liter (ug/L)
Standard Error 1.3
|
0.0 microgram/liter (ug/L)
Standard Error 1.4
|
-2.6 microgram/liter (ug/L)
Standard Error 1.2
|
-0.2 microgram/liter (ug/L)
Standard Error 1.4
|
0.3 microgram/liter (ug/L)
Standard Error 1.0
|
1.2 microgram/liter (ug/L)
Standard Error 1.1
|
|
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])
Bone-Specific ALP
|
-0.1 microgram/liter (ug/L)
Standard Error 0.9
|
-0.2 microgram/liter (ug/L)
Standard Error 1.0
|
-1.9 microgram/liter (ug/L)
Standard Error 1.0
|
-1.9 microgram/liter (ug/L)
Standard Error 0.9
|
-0.3 microgram/liter (ug/L)
Standard Error 1.0
|
-2.3 microgram/liter (ug/L)
Standard Error 0.7
|
0.4 microgram/liter (ug/L)
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug.
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])
Beta-Crosslaps
|
-0.033 nanogram/milliliter (ng/mL)
Standard Error 0.052
|
-0.023 nanogram/milliliter (ng/mL)
Standard Error 0.051
|
0.001 nanogram/milliliter (ng/mL)
Standard Error 0.053
|
0.004 nanogram/milliliter (ng/mL)
Standard Error 0.048
|
0.031 nanogram/milliliter (ng/mL)
Standard Error 0.054
|
-0.010 nanogram/milliliter (ng/mL)
Standard Error 0.040
|
-0.038 nanogram/milliliter (ng/mL)
Standard Error 0.042
|
|
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])
P1NP
|
-0.3 nanogram/milliliter (ng/mL)
Standard Error 3.4
|
0.9 nanogram/milliliter (ng/mL)
Standard Error 3.5
|
1.9 nanogram/milliliter (ng/mL)
Standard Error 3.5
|
-6.8 nanogram/milliliter (ng/mL)
Standard Error 3.2
|
-0.2 nanogram/milliliter (ng/mL)
Standard Error 3.8
|
2.3 nanogram/milliliter (ng/mL)
Standard Error 2.9
|
5.0 nanogram/milliliter (ng/mL)
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug.
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=8 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=7 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
n=8 Participants
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
n=10 Participants
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=10 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint
Total Hip
|
-0.6 milligram/square centimeter (mg/cm2)
Standard Error 1.2
|
-0.7 milligram/square centimeter (mg/cm2)
Standard Error 1.2
|
-1.0 milligram/square centimeter (mg/cm2)
Standard Error 1.2
|
0.1 milligram/square centimeter (mg/cm2)
Standard Error 1.1
|
-0.7 milligram/square centimeter (mg/cm2)
Standard Error 1.3
|
-1.0 milligram/square centimeter (mg/cm2)
Standard Error 0.8
|
0.2 milligram/square centimeter (mg/cm2)
Standard Error 1.0
|
|
Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint
L1-L4 Intervertebral Space
|
-0.4 milligram/square centimeter (mg/cm2)
Standard Error 1.9
|
1.2 milligram/square centimeter (mg/cm2)
Standard Error 2.0
|
1.0 milligram/square centimeter (mg/cm2)
Standard Error 2.1
|
2.0 milligram/square centimeter (mg/cm2)
Standard Error 1.8
|
1.6 milligram/square centimeter (mg/cm2)
Standard Error 2.1
|
1.8 milligram/square centimeter (mg/cm2)
Standard Error 1.4
|
1.4 milligram/square centimeter (mg/cm2)
Standard Error 1.6
|
|
Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint
Neck of Femur
|
-0.6 milligram/square centimeter (mg/cm2)
Standard Error 1.9
|
-0.4 milligram/square centimeter (mg/cm2)
Standard Error 2.0
|
-0.8 milligram/square centimeter (mg/cm2)
Standard Error 2.0
|
-0.3 milligram/square centimeter (mg/cm2)
Standard Error 1.8
|
-1.2 milligram/square centimeter (mg/cm2)
Standard Error 2.1
|
-2.1 milligram/square centimeter (mg/cm2)
Standard Error 1.4
|
0.2 milligram/square centimeter (mg/cm2)
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetics
AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.
Outcome measures
| Measure |
7 mg LY3053102
n=8 Participants
7 mg LY3053102 administered SC Q1W for 12 weeks
|
15 mg LY3053102
n=7 Participants
15 mg LY3053102 administered SC Q1W for 12 weeks
|
50 mg LY3053102
n=8 Participants
50 mg LY3053102 50 mg administered SC Q1W for 12 weeks
|
100 mg LY3053102
n=8 Participants
100 mg LY3053102 administered SC Q1W for 12 weeks
|
200 mg LY3053102
200 mg LY3053102 administered SC Q1W for 12 weeks
|
2 mg Exenatide ER
2 mg exenatide ER administered SC Q1W for 12 weeks
|
Placebo
n=8 Participants
Placebo administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102
|
76.8 microgram•hour/milliliter (µg•h/mL)
Geometric Coefficient of Variation 25.6
|
190.0 microgram•hour/milliliter (µg•h/mL)
Geometric Coefficient of Variation 47.3
|
350.0 microgram•hour/milliliter (µg•h/mL)
Geometric Coefficient of Variation 36.3
|
917.0 microgram•hour/milliliter (µg•h/mL)
Geometric Coefficient of Variation 35.1
|
—
|
—
|
22.6 microgram•hour/milliliter (µg•h/mL)
Geometric Coefficient of Variation 32.1
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
7 mg LY3053102
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
15 mg LY3053102
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
50 mg LY3053102
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
100 mg LY3053102
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
200 mg LY3053102
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
2 mg Exenatide ER
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo administered by SC QW for 12 weeks
|
7 mg LY3053102
n=8 participants at risk
7 mg LY3053102 administered SC QW for 12 weeks
|
15 mg LY3053102
n=8 participants at risk
15 mg LY3053102 administered SC QW for 12 weeks
|
50 mg LY3053102
n=7 participants at risk
50 mg LY3053102 administered SC QW for 12 weeks
|
100 mg LY3053102
n=8 participants at risk
100 mg LY3053102 administered SC QW for 12 weeks
|
200 mg LY3053102
n=8 participants at risk
200 mg LY3053102 administered SC QW for 12 weeks
|
2 mg Exenatide ER
n=10 participants at risk
2 mg exenatide ER administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo administered by SC QW for 12 weeks
|
7 mg LY3053102
n=8 participants at risk
7 mg LY3053102 administered SC QW for 12 weeks
|
15 mg LY3053102
n=8 participants at risk
15 mg LY3053102 administered SC QW for 12 weeks
|
50 mg LY3053102
n=7 participants at risk
50 mg LY3053102 administered SC QW for 12 weeks
|
100 mg LY3053102
n=8 participants at risk
100 mg LY3053102 administered SC QW for 12 weeks
|
200 mg LY3053102
n=8 participants at risk
200 mg LY3053102 administered SC QW for 12 weeks
|
2 mg Exenatide ER
n=10 participants at risk
2 mg exenatide ER administered SC QW for 12 weeks
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
75.0%
6/8 • Number of events 9
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
50.0%
4/8 • Number of events 6
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
50.0%
4/8 • Number of events 5
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Asthenia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
37.5%
3/8 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Chills
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site discolouration
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site erosion
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site erythema
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 4
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
50.0%
4/8 • Number of events 7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site haematoma
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
62.5%
5/8 • Number of events 7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site induration
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site nodule
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site pain
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
28.6%
2/7 • Number of events 4
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 4
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site reaction
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Injection site urticaria
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Malaise
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
General disorders
Thirst
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Immune system disorders
Seasonal allergy
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
28.6%
2/7 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
62.5%
5/8 • Number of events 5
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Blood glucose increased
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Lipase increased
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
30.0%
3/10 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Investigations
Weight increased
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
20.0%
2/10 • Number of events 8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Metabolism and nutrition disorders
Increased appetite
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
28.6%
2/7 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
37.5%
3/8 • Number of events 3
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
50.0%
4/8 • Number of events 5
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
20.0%
2/10 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Renal and urinary disorders
Nephrolithiasis
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
14.3%
1/7 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
12.5%
1/8 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
10.0%
1/10 • Number of events 1
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/7
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
25.0%
2/8 • Number of events 2
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/8
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
0.00%
0/10
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
|
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