Trial Outcomes & Findings for Weight Loss With Exenatide Treatment (NCT NCT01590433)
NCT ID: NCT01590433
Last Updated: 2021-06-23
Results Overview
Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
249 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-06-23
Participant Flow
249 subjects provided informed consent, 182 were randomized. I am reporting that 249 subjects were enrolled according to our local IRB definition of enrollment. 182 started study treatment. 67 subjects who did not start treatment were either found to be ineligible based on screening labs; withdrew consent; or were lost to followup.
Participant milestones
| Measure |
Exenatide
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
Placebo
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
55
|
|
Overall Study
COMPLETED
|
75
|
33
|
|
Overall Study
NOT COMPLETED
|
52
|
22
|
Reasons for withdrawal
| Measure |
Exenatide
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
Placebo
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
8
|
|
Overall Study
Withdrawal by Subject
|
21
|
11
|
|
Overall Study
Adverse Event
|
11
|
3
|
Baseline Characteristics
Weight Loss With Exenatide Treatment
Baseline characteristics by cohort
| Measure |
Exenatide
n=127 Participants
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
Placebo
n=55 Participants
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
55 participants
n=7 Participants
|
182 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: subjects randomized to exenatide or placebo
Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.
Outcome measures
| Measure |
Exenatide
n=75 Participants
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
Placebo
n=33 Participants
Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group.
Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.
|
|---|---|---|
|
Change in Body Weight
|
6.5 percentage weight loss
Standard Deviation 0.4
|
7.5 percentage weight loss
Standard Deviation 0.6
|
Adverse Events
Exenatide
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide
n=127 participants at risk
Exenatide: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
|
Placebo
n=55 participants at risk
Placebo: Subjects will inject 5mcg of exenatide or identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
Dietary counseling: All subjects will also receive individualized dietary counseling. Subjects may or may not be asked to follow a reduced calorie diet in addition to receiving treatment.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
70.1%
89/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
25.5%
14/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Gastrointestinal disorders
diarrhea
|
18.9%
24/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
16.4%
9/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Gastrointestinal disorders
vomiting
|
12.6%
16/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
1.8%
1/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Gastrointestinal disorders
reflux
|
15.7%
20/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
16.4%
9/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Nervous system disorders
headache
|
26.8%
34/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
23.6%
13/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Metabolism and nutrition disorders
decreased appetite
|
40.9%
52/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
23.6%
13/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
|
Skin and subcutaneous tissue disorders
rash
|
11.0%
14/127 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
1.8%
1/55 • Entire study duration, up to 1 year
Adverse events and serious adverse events are defined according to clinicaltrials.gov definition. Adverse event information was collected at each study visit, in person.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place