Phase 4
Completed N=41
The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
Source: ClinicalTrials.gov NCT00456885 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Change in Weight — -2.49; 0.43 kilograms
◆ Published Evidence
Highly cited
154citations · ~11 / year
Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes.
Summary
This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.
The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo.
Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.
Linked Publications
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Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-2.49; 0.43 | — |
| PRIMARY Change in Body Mass Index |
-0.93; 0.18 | — |
| SECONDARY Change in Waist Circumference |
-1.68; 0.94 | — |
| SECONDARY Systolic Blood Pressure |
-2.5; -1.3 | — |
| SECONDARY Changes in Body Composition |
-0.4; -0.7 | — |
| SECONDARY Changes in Leptin |
-3.7; -0.2 | — |
| SECONDARY Diastolic Blood Pressure |
-1.2; -0.4 | — |
| SECONDARY Adiponectin |
0.4; 0.07 | — |
| SECONDARY Change in Insulin |
1.1; 0.4 | — |
| SECONDARY Change in Fasting Glucose |
0.5; 3.1 | — |
| SECONDARY Change in Two Hour Glucose |
-10; -0.5 | — |
| SECONDARY HOMA Score |
0.2; 0.2 | — |
| SECONDARY REE |
-13.7; 6.5 | — |
Eligibility Criteria
Inclusion Criteria
- Females aged 25-60
- BMI 28-35 kg/m2
- No known diagnosis of diabetes
- No known diagnosis of coronary heart disease
- Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
- Stable weight (variation 150/90 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)
- Tobacco, marijuana or intravenous drug use
- Shift workers (night shift or alternating day/night shifts)
- Recent weight loss (> 3 kg within 4 months of the screening visit)
- Gastroparesis
- Inflammatory bowel disease
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression requiring hospitalization or diagnosis of psychosis
- Renal insufficiency (creatinine clearance 2x above the normal range
- Pregnancy within 6 months of the screening visit
- Breastfeeding
- Failure to use medically approved contraceptive methods
- History of an eating disorder (anorexia, bulimia or laxative abuse)
- History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
- Previous participation in a clinical study with exenatide
- Presence or history of allergic reaction to multiple drugs
Data sourced from ClinicalTrials.gov (NCT00456885) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.