Trial Outcomes & Findings for Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults (NCT NCT00845507)
NCT ID: NCT00845507
Last Updated: 2018-04-20
Results Overview
Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
54 participants
Primary outcome timeframe
16 Weeks
Results posted on
2018-04-20
Participant Flow
Participant milestones
| Measure |
Exenatide Group
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
30
|
|
Overall Study
COMPLETED
|
22
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults
Baseline characteristics by cohort
| Measure |
Exenatide Group
n=24 Participants
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
n=30 Participants
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 9.3 • n=39 Participants
|
39.3 years
STANDARD_DEVIATION 11.7 • n=41 Participants
|
41.4 years
STANDARD_DEVIATION 10.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=39 Participants
|
30 participants
n=41 Participants
|
54 participants
n=35 Participants
|
|
Weight
|
197 Pounds
STANDARD_DEVIATION 32 • n=39 Participants
|
209 Pounds
STANDARD_DEVIATION 51 • n=41 Participants
|
204 Pounds
STANDARD_DEVIATION 44 • n=35 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksPopulation: All subjects who took at least one dose of study medication and had one post-baseline evaluation.
Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).
Outcome measures
| Measure |
Exenatide Group
n=22 Participants
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
n=29 Participants
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
|---|---|---|
|
Change in Weight From Baseline to Endpoint.
|
-1.1 Pounds
Standard Deviation 6.2
|
5.9 Pounds
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: All subjects who took at least one dose of study medication and had one post-baseline evaluation.
Secondary outcome measures included change in body mass index (BMI).
Outcome measures
| Measure |
Exenatide Group
n=22 Participants
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
n=29 Participants
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
|---|---|---|
|
Change in Body Mass Index (BMI) From Baseline to Endpoint.
|
-0.2 Kgs/meter squared
Standard Deviation 1.0
|
1.0 Kgs/meter squared
Standard Deviation 1.7
|
Adverse Events
Exenatide Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide Group
n=24 participants at risk
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
n=30 participants at risk
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for exacerbation of depressive symptoms
|
4.2%
1/24 • Number of events 1 • Up to 16 weeks
|
3.3%
1/30 • Number of events 1 • Up to 16 weeks
|
|
Gastrointestinal disorders
Hospitalization for Mallory-Weiss tear
|
4.2%
1/24 • Number of events 1 • Up to 16 weeks
|
0.00%
0/30 • Up to 16 weeks
|
Other adverse events
| Measure |
Exenatide Group
n=24 participants at risk
Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
Placebo Group
n=30 participants at risk
Placebo: Sterile solution in equivalent doses as Exenatide
Exenatide: The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Gastointestinal disturbance (includes acid reflux, constipation, diarrhea, heartburn, nausea etc)
|
58.3%
14/24 • Number of events 14 • Up to 16 weeks
|
36.7%
11/30 • Number of events 11 • Up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place