A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Status and phase
Completed
Phase 2
Conditions
Obesity
Treatments
Drug: placebo
Drug: exenatide
Details and patient eligibility
About
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Enrollment
163 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Have a Body Mass Index (BMI) >= 30kg/m^2
Exclusion criteria
- Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
- Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
- Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
- Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
- Have been treated with any anti-diabetic medications within 3 months of screening
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
- Have had bariatric surgery
- Have had an organ transplant
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
163 participants in 2 patient groups, including a placebo group
Group A
Experimental group
Treatment:
Drug: exenatide
Group B
Placebo Comparator group
Treatment:
Drug: placebo
Trial contacts and locations
16
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Data sourced from clinicaltrials.gov
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