Trial Outcomes & Findings for A Study of Dulaglutide in Chinese Participants (NCT NCT01667900)
NCT ID: NCT01667900
Last Updated: 2016-03-07
Results Overview
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
0.5 mg Dulaglutide (Part B-T2DM)
0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
Placebo (Part B-T2DM)
Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, Period 1
STARTED
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 1
COMPLETED
|
1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 1
NOT COMPLETED
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0
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0
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0
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0
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Part A, Washout 1
STARTED
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Washout 1
COMPLETED
|
1
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1
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1
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1
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1
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1
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0
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0
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0
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Part A, Washout 1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part A, Period 2
STARTED
|
1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 2
COMPLETED
|
1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 2
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part A, Washout 2
STARTED
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Washout 2
COMPLETED
|
1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Washout 2
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part A, Period 3
STARTED
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 3
COMPLETED
|
1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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1
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0
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0
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0
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0
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Part A, Period 3
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part B
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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11
|
11
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10
|
10
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Part B
COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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10
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11
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10
|
10
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Part B
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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Reasons for withdrawal
| Measure |
First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: 1.5 mg dulaglutide administered once SQ
|
First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.75 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.5 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 0.75 mg dulaglutide administered once SQ
Period 2: placebo administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.75 mg dulaglutide administered once SQ
|
First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: 1.5 mg dulaglutide administered once SQ
Period 2: 0.5 mg dulaglutide administered once SQ
Period 3: placebo administered once SQ
|
First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)
Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.
Period 1: placebo administered once SQ
Period 2: 1.5 mg dulaglutide administered once SQ
Period 3: 0.5 mg dulaglutide administered once SQ
|
0.5 mg Dulaglutide (Part B-T2DM)
0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
Placebo (Part B-T2DM)
Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Dulaglutide in Chinese Participants
Baseline characteristics by cohort
| Measure |
Part A-Healthy
n=16 Participants
Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 Participants
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
Placebo (Part B-T2DM)
n=10 Participants
Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
51.8 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
48.4 years
STANDARD_DEVIATION 14.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
46 Participants
n=8 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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
58 Participants
n=8 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
58 Participants
n=8 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
|
|
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=8 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=8 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
|
|
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
|
|
Region of Enrollment
China
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
58 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dosePopulation: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Outcome measures
| Measure |
0.5 mg Dulaglutide (Part A-Healthy)
n=10 Participants
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 Participants
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 Participants
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
Day 1 (Parts A and B)
|
29.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
44.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
81.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
20.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
31.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
52.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
Day 22 (Part B only)
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
26.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
41.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
70.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
PRIMARY outcome
Timeframe: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dosePopulation: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Outcome measures
| Measure |
0.5 mg Dulaglutide (Part A-Healthy)
n=10 Participants
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 Participants
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 Participants
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide
Day 1 (Parts A and B)
|
48.02 hours
Interval 12.02 to 48.02
|
48.00 hours
Interval 24.0 to 48.0
|
48.00 hours
Interval 24.0 to 48.0
|
48.00 hours
Interval 47.92 to 72.0
|
48.00 hours
Interval 24.0 to 72.0
|
71.98 hours
Interval 24.0 to 96.0
|
|
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide
Day 22 (Part B only)
|
NA hours
Part A participants did not have data collected at this time point
|
NA hours
Part A participants did not have data collected at this time point
|
NA hours
Part A participants did not have data collected at this time point
|
48.00 hours
Interval 12.0 to 48.02
|
47.98 hours
Interval 24.0 to 48.0
|
48.00 hours
Interval 23.97 to 96.0
|
PRIMARY outcome
Timeframe: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dosePopulation: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Outcome measures
| Measure |
0.5 mg Dulaglutide (Part A-Healthy)
n=10 Participants
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 Participants
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 Participants
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 Participants
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide
Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)
|
4500 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
6410 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
11700 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 12
|
3900 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 7
|
5490 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 19
|
10300 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
|
Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide
Day 22 (Part B only; n = 6, 10, 10
|
NA nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
NA nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
NA nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Part A participants did not have data collected at this time point
|
4720 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 7
|
7030 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
12500 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 15
|
PRIMARY outcome
Timeframe: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dosePopulation: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Outcome measures
| Measure |
0.5 mg Dulaglutide (Part A-Healthy)
n=10 Participants
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 Participants
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.5 mg Dulaglutide (Part B-T2DM)
n=6 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
n=10 Participants
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
n=9 Participants
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Half-life of Dulaglutide
Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)
|
85.1 hours
Interval 50.8 to 244.0
|
84.5 hours
Interval 60.2 to 228.0
|
82.9 hours
Interval 63.8 to 104.0
|
122 hours
Interval 106.0 to 133.0
|
113 hours
Interval 63.9 to 222.0
|
88.5 hours
Interval 69.6 to 111.0
|
|
Pharmacokinetics: Half-life of Dulaglutide
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)
|
NA hours
Part A participants did not have data collected at this time point
|
NA hours
Part A participants did not have data collected at this time point
|
NA hours
Part A participants did not have data collected at this time point
|
97.6 hours
Interval 71.9 to 122.0
|
106 hours
Interval 70.4 to 139.0
|
105 hours
Interval 80.0 to 134.0
|
SECONDARY outcome
Timeframe: Baseline and Days 3, 24, and 29Population: Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.
Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.
Outcome measures
| Measure |
0.5 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 Participants
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
1.5 mg Dulaglutide (Part A-Healthy)
n=10 Participants
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
|
0.5 mg Dulaglutide (Part B-T2DM)
n=10 Participants
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
0.75 mg Dulaglutide (Part B-T2DM)
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
1.5 mg Dulaglutide (Part B-T2DM)
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
|
|---|---|---|---|---|---|---|
|
Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])
Baseline
|
44.3 millimoles*hours per liter (mmol*h/L)
Standard Deviation 10.6
|
58.1 millimoles*hours per liter (mmol*h/L)
Standard Deviation 11.7
|
53.4 millimoles*hours per liter (mmol*h/L)
Standard Deviation 8.12
|
48.2 millimoles*hours per liter (mmol*h/L)
Standard Deviation 7.00
|
—
|
—
|
|
Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])
Day 3
|
34.2 millimoles*hours per liter (mmol*h/L)
Standard Deviation 6.19
|
41.2 millimoles*hours per liter (mmol*h/L)
Standard Deviation 11.9
|
32.2 millimoles*hours per liter (mmol*h/L)
Standard Deviation 4.87
|
46.1 millimoles*hours per liter (mmol*h/L)
Standard Deviation 8.94
|
—
|
—
|
|
Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])
Day 24
|
34.7 millimoles*hours per liter (mmol*h/L)
Standard Deviation 7.11
|
36.8 millimoles*hours per liter (mmol*h/L)
Standard Deviation 7.08
|
30.5 millimoles*hours per liter (mmol*h/L)
Standard Deviation 4.55
|
48.6 millimoles*hours per liter (mmol*h/L)
Standard Deviation 9.10
|
—
|
—
|
|
Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])
Day 29
|
37.6 millimoles*hours per liter (mmol*h/L)
Standard Deviation 9.11
|
38.1 millimoles*hours per liter (mmol*h/L)
Standard Deviation 7.40
|
31.8 millimoles*hours per liter (mmol*h/L)
Standard Deviation 4.57
|
46.9 millimoles*hours per liter (mmol*h/L)
Standard Deviation 6.68
|
—
|
—
|
Adverse Events
Placebo (Part A-Healthy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.5 mg Dulaglutide (Part A-Healthy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.75 mg Dulaglutide (Part A-Healthy)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1.5 mg Dulaglutide (Part A-Healthy)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (Part B-T2DM)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.5 mg Dulaglutide (Part B-T2DM)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
0.75 mg Dulaglutide (Part B-T2DM)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1.5 mg Dulaglutide (Part B-T2DM)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A-Healthy)
n=16 participants at risk
Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.5 mg Dulaglutide (Part A-Healthy)
n=10 participants at risk
0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 participants at risk
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 participants at risk
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
Placebo (Part B-T2DM)
n=10 participants at risk
Placebo administered to participants with T2DM once weekly SQ for 4 weeks
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 participants at risk
0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 participants at risk
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 participants at risk
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
Other adverse events
| Measure |
Placebo (Part A-Healthy)
n=16 participants at risk
Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.5 mg Dulaglutide (Part A-Healthy)
n=10 participants at risk
0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.75 mg Dulaglutide (Part A-Healthy)
n=11 participants at risk
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
1.5 mg Dulaglutide (Part A-Healthy)
n=11 participants at risk
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
Placebo (Part B-T2DM)
n=10 participants at risk
Placebo administered to participants with T2DM once weekly SQ for 4 weeks
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.5 mg Dulaglutide (Part B-T2DM)
n=11 participants at risk
0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
0.75 mg Dulaglutide (Part B-T2DM)
n=11 participants at risk
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
1.5 mg Dulaglutide (Part B-T2DM)
n=10 participants at risk
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Dulaglutide
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Blood pressure decreased
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Blood pressure increased
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Heart rate abnormal
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
18.2%
2/11 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Nervous system disorders
Tremor
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
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