Trial Outcomes & Findings for A Study of LY2922083 in Healthy Participants and Participants With Diabetes (NCT NCT01748552)
NCT ID: NCT01748552
Last Updated: 2019-08-08
Results Overview
Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Baseline through study completion (up to 70 days)
Results posted on
2019-08-08
Participant Flow
Single ascending dose crossover study with 2 parts and 3 periods per part. Part A had 3 cohorts (healthy participants). Part B had 1 cohort \[with type 2 diabetes mellitus (T2DM)\]. Participants in Part A, Cohort 3 completed 2 periods, as ninth (contingency) dose not tested based on interim data. There was ≥10 days between dosing for any participant.
Participant milestones
| Measure |
Part A, Cohort 1, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 1.5 milligrams (mg) LY2922083
Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083
Period 2: Placebo
Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083
Period 2: 1.5 mg LY2922083
Period 3: Placebo
|
Part A, Cohort 2, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 50 mg LY2922083
Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083
Period 2: Placebo
Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083
Period 2: 50 mg LY2922083
Period 3: Placebo
|
Part A, Cohort 3, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 845 mg LY2922083
|
Part A, Cohort 3, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083
Period 2: Placebo
|
Part A, Cohort 3, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083
Period 2: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 1
Participants with T2DM received a single oral dose of the following:
Period 1: Placebo
Period 2: 450 mg LY2922083
Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 2
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083
Period 2: Placebo
Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 3
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083
Period 2: 450 mg LY2922083
Period 3: Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intervention Period 1 and Washout
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 1 and Washout
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 1 and Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2 and Washout
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Intervention Period 2 and Washout
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
0
|
0
|
0
|
3
|
3
|
3
|
|
Intervention Period 2 and Washout
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
3
|
3
|
0
|
0
|
0
|
|
Intervention Period 3 and Washout
STARTED
|
3
|
3
|
2
|
3
|
3
|
3
|
0
|
0
|
0
|
3
|
3
|
3
|
|
Intervention Period 3 and Washout
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
0
|
0
|
0
|
3
|
3
|
3
|
|
Intervention Period 3 and Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A, Cohort 1, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 1.5 milligrams (mg) LY2922083
Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083
Period 2: Placebo
Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083
Period 2: 1.5 mg LY2922083
Period 3: Placebo
|
Part A, Cohort 2, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 50 mg LY2922083
Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083
Period 2: Placebo
Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083
Period 2: 50 mg LY2922083
Period 3: Placebo
|
Part A, Cohort 3, Sequence 1
Healthy participants received a single oral dose of the following:
Period 1: Placebo
Period 2: 845 mg LY2922083
|
Part A, Cohort 3, Sequence 2
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083
Period 2: Placebo
|
Part A, Cohort 3, Sequence 3
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083
Period 2: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 1
Participants with T2DM received a single oral dose of the following:
Period 1: Placebo
Period 2: 450 mg LY2922083
Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 2
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083
Period 2: Placebo
Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 3
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083
Period 2: 450 mg LY2922083
Period 3: Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intervention Period 2 and Washout
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2 and Washout
Contingency dose not tested
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Part A, Cohort 1, Sequence 1
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: Placebo Period 2: 1.5 milligrams (mg) LY2922083 Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 2
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083 Period 2: Placebo Period 3: 5 mg LY2922083
|
Part A, Cohort 1, Sequence 3
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 0.5 mg LY2922083 Period 2: 1.5 mg LY2922083 Period 3: Placebo
|
Part A, Cohort 2, Sequence 1
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: Placebo Period 2: 50 mg LY2922083 Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 2
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083 Period 2: Placebo Period 3: 150 mg LY2922083
|
Part A, Cohort 2, Sequence 3
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 15 mg LY2922083 Period 2: 50 mg LY2922083 Period 3: Placebo
|
Part A, Cohort 3, Sequence 1
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: Placebo Period 2: 845 mg LY2922083
|
Part A, Cohort 3, Sequence 2
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083 Period 2: Placebo
|
Part A, Cohort 3, Sequence 3
n=3 Participants
Healthy participants received a single oral dose of the following:
Period 1: 450 mg LY2922083 Period 2: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 1
n=3 Participants
Participants with T2DM received a single oral dose of the following:
Period 1: Placebo Period 2: 450 mg LY2922083 Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 2
n=3 Participants
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083 Period 2: Placebo Period 3: 845 mg LY2922083
|
Part B, Cohort 1, Sequence 3
n=3 Participants
Participants with T2DM received a single oral dose of the following:
Period 1: 150 mg LY2922083 Period 2: 450 mg LY2922083 Period 3: Placebo
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
Singapore
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
34 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
36 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
35 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to 70 days)Population: Safety population: all participants who received at least 1 dose of study drug or placebo, and had at least 1 postdose safety assessment.
Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
0.5 mg LY2922083 (Part A)
n=32 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part A)
n=12 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
|
845 mg LY2922083 (Part A)
n=12 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part B)
n=12 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)Population: All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate AUC(0-∞).
Outcome measures
| Measure |
0.5 mg LY2922083 (Part A)
n=5 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
|
845 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083
|
25.9 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
79.5 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
220 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 52
|
612 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
1560 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
3270 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
10200 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
16900 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
4900 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 117
|
10400 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 60
|
24400 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 89
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)Population: All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate Cmax.
Outcome measures
| Measure |
0.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
|
845 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY2922083
|
2.36 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
8.64 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
20.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
66.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
152 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
327 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
927 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
1720 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
407 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 131
|
808 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
2220 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose)Population: All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate glucose AUEC(0-24).
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Outcome measures
| Measure |
0.5 mg LY2922083 (Part A)
n=23 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
|
845 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Part B)
n=9 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]
|
7.08 millimoles*hour per liter (mmol*h/L)
Standard Error 1.17
|
6.32 millimoles*hour per liter (mmol*h/L)
Standard Error 2.86 • Interval -5.4 to 3.9
|
-0.02 millimoles*hour per liter (mmol*h/L)
Standard Error 2.84 • Interval -11.7 to -2.49
|
12.34 millimoles*hour per liter (mmol*h/L)
Standard Error 2.78 • Interval 0.2 to 10.34
|
8.88 millimoles*hour per liter (mmol*h/L)
Standard Error 3.00 • Interval -2.93 to 6.55
|
8.40 millimoles*hour per liter (mmol*h/L)
Standard Error 2.94 • Interval -3.32 to 5.98
|
4.78 millimoles*hour per liter (mmol*h/L)
Standard Error 2.73 • Interval -7.24 to 2.65
|
6.13 millimoles*hour per liter (mmol*h/L)
Standard Error 2.87 • Interval -6.0 to 4.11
|
3.68 millimoles*hour per liter (mmol*h/L)
Standard Error 2.87 • Interval -8.45 to 1.65
|
4.60 millimoles*hour per liter (mmol*h/L)
Standard Error 1.90
|
8.48 millimoles*hour per liter (mmol*h/L)
Standard Error 3.56 • Interval 7.92 to 24.85
|
1.18 millimoles*hour per liter (mmol*h/L)
Standard Error 3.18 • Interval -26.99 to 10.89
|
3.05 millimoles*hour per liter (mmol*h/L)
Standard Error 3.24 • Interval -26.92 to -12.05
|
SECONDARY outcome
Timeframe: Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose)Population: All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate C-peptide AUEC(0-6).
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Outcome measures
| Measure |
0.5 mg LY2922083 (Part A)
n=23 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1.
|
845 mg LY2922083 (Part A)
n=6 Participants
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Part B)
n=9 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
450 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Part B)
n=6 Participants
Participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)]
|
6638.85 picomoles*hour per liter (pmol*h/L)
Standard Error 557.21
|
6518.87 picomoles*hour per liter (pmol*h/L)
Standard Error 1195.43
|
8107.68 picomoles*hour per liter (pmol*h/L)
Standard Error 1194.99
|
5742.81 picomoles*hour per liter (pmol*h/L)
Standard Error 1172.87
|
8283.17 picomoles*hour per liter (pmol*h/L)
Standard Error 1225.04
|
6715.88 picomoles*hour per liter (pmol*h/L)
Standard Error 1221.10
|
5653.51 picomoles*hour per liter (pmol*h/L)
Standard Error 1140.26
|
4525.49 picomoles*hour per liter (pmol*h/L)
Standard Error 1204.61
|
5554.47 picomoles*hour per liter (pmol*h/L)
Standard Error 1203.47
|
1670.60 picomoles*hour per liter (pmol*h/L)
Standard Error 580.54
|
2865.28 picomoles*hour per liter (pmol*h/L)
Standard Error 1174.05
|
1061.59 picomoles*hour per liter (pmol*h/L)
Standard Error 1178.54
|
512.14 picomoles*hour per liter (pmol*h/L)
Standard Error 1180.77
|
Adverse Events
Placebo (Parts A and B)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
0.5 mg LY2922083 (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1.5 mg LY2922083 (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
5 mg LY2922083 (Part A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
15 mg LY2922083 (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
50 mg LY2922083 (Part A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
150 mg LY2922083 (Parts A and B)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
450 mg LY2922083 (Parts A and B)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
845 mg LY2922083 (Parts A and B)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Parts A and B)
n=32 participants at risk
Healthy participants or participants with T2DM, in Part A or B, Cohorts 1, 2, or 3, who received a single oral dose of placebo in 1 of 3 study periods.
|
0.5 mg LY2922083 (Part A)
n=6 participants at risk
Healthy participants in Part A, Cohort 1 who received a single oral dose of 0.5 mg LY2922083 in study period 1.
|
1.5 mg LY2922083 (Part A)
n=6 participants at risk
Healthy participants in Part A, Cohort 1 who received a single oral dose of 1.5 mg LY2922083 in study period 2.
|
5 mg LY2922083 (Part A)
n=6 participants at risk
Healthy participants in Part A, Cohort 1 who received a single oral dose of 5 mg LY2922083 in study period 3.
|
15 mg LY2922083 (Part A)
n=6 participants at risk
Healthy participants in Part A, Cohort 2 who received a single oral dose of 15 mg LY2922083 in study period 1.
|
50 mg LY2922083 (Part A)
n=6 participants at risk
Healthy participants in Part A, Cohort 2 who received a single oral dose of 50 mg LY2922083 in study period 2.
|
150 mg LY2922083 (Parts A and B)
n=12 participants at risk
Healthy participants in Part A, Cohort 2 who received a single oral dose of 150 mg LY2922083 in study period 3 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 150 mg LY2922083 in study period 1.
|
450 mg LY2922083 (Parts A and B)
n=12 participants at risk
Healthy participants in Part A, Cohort 3 who received a single oral dose of 450 mg LY2922083 in study period 1 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 450 mg LY2922083 in study period 2.
|
845 mg LY2922083 (Parts A and B)
n=12 participants at risk
Healthy participants in Part A, Cohort 3 who received a single oral dose of 845 mg LY2922083 in study period 2 and participants with T2DM in Part B, Cohort 1 who received a single oral dose of 845 mg LY2922083 in study period 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Catheter site erythema
|
3.1%
1/32 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Catheter site haematoma
|
6.2%
2/32 • Number of events 2 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Catheter site pain
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Catheter site swelling
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Fatigue
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
General disorders
Pyrexia
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
|
General disorders
Vessel puncture site haematoma
|
6.2%
2/32 • Number of events 2 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
16.7%
2/12 • Number of events 2 • Baseline through study completion (up to 70 days)
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Infections and infestations
Abscess
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.1%
1/32 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
9.4%
3/32 • Number of events 4 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
2/12 • Number of events 3 • Baseline through study completion (up to 70 days)
|
16.7%
2/12 • Number of events 3 • Baseline through study completion (up to 70 days)
|
25.0%
3/12 • Number of events 4 • Baseline through study completion (up to 70 days)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
1/32 • Number of events 1 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
0.00%
0/6 • Baseline through study completion (up to 70 days)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to 70 days)
|
25.0%
3/12 • Number of events 4 • Baseline through study completion (up to 70 days)
|
0.00%
0/12 • Baseline through study completion (up to 70 days)
|
8.3%
1/12 • Number of events 1 • Baseline through study completion (up to 70 days)
|
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