The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Amylin Pharmaceuticals, LLC.; Eli Lilly and Company
• Treatments: Exenatide

Criteria

Inclusion Criteria:

1. Females aged 25-60

2. BMI 28-35 kg/m2

3. No known diagnosis of diabetes

4. No known diagnosis of coronary heart disease

5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)

6. Stable weight (variation < 3 kg within 6 months of screening visit)

7. Ability to give informed consent

8. Ability to follow verbal and written instructions

9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)

10. Nonsmoker (tobacco, marijuana)

11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary.

Exclusion Criteria:

1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria

2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris)

3. Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive medication)

4. Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)

5. Tobacco, marijuana or intravenous drug use

6. Shift workers (night shift or alternating day/night shifts)

7. Recent weight loss (> 3 kg within 4 months of the screening visit)

8. Gastroparesis

9. Inflammatory bowel disease

10. Malignancy treated with chemotherapy within the past 3 years

11. History of pancreatitis

12. Depression requiring hospitalization or diagnosis of psychosis

13. Renal insufficiency (creatinine clearance < 50 ml/min)

14. Transaminases > 2x above the normal range

15. Pregnancy within 6 months of the screening visit

16. Breastfeeding

17. Failure to use medically approved contraceptive methods

18. History of an eating disorder (anorexia, bulimia or laxative abuse)

19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)

20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit

21. Previous participation in a clinical study with exenatide

22. Presence or history of allergic reaction to multiple drugs