This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center Identifier:
First received: April 4, 2007
Last updated: February 24, 2012
Last verified: February 2012

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.

Condition Intervention Phase
Obesity Impaired Glucose Tolerance Drug: exenatide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • weight loss [ Time Frame: 37 Weeks ]

Secondary Outcome Measures:
  • Changes in resting and total energy expenditure [ Time Frame: 37 Weeks ]
  • Changes in sleep patterns [ Time Frame: 37 Weeks ]
  • Changes in hunger, satiety and nausea [ Time Frame: 37 Weeks ]
  • Changes in food intake [ Time Frame: 37 Weeks ]
  • Changes in metabolic parameters [ Time Frame: 37 Weeks ]
  • Changes in body composition [ Time Frame: 37 Weeks ]
  • Changes in inflammatory markers [ Time Frame: 37 Weeks ]

Enrollment: 42
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: exenatide
    5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks
    Other Name: Byetta
Detailed Description:

This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired fasting glucose (IFG, fasting glucose 101-125 mg/dL) or impaired glucose tolerance (IGT, glucose 140-199 mg/dL 2h after a 75g oral glucose load). This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period. There are 19 study visits over 35 weeks.

The goals of this study are 1) to examine the effect of exenatide on body weight and dysglycemia in populations in which this medication has not been studied, namely obese women with and without IGH and 2) to investigate possible mechanisms of weight loss through measurements of energy expenditure, hunger, satiety, nausea, and sleep.

The primary outcome of this study is weight loss. We will calculate absolute and relative change in body weight from baseline to week 16 (the first treatment period) and from week 19 to week 35 (the second treatment period). Body weight will be measured at every study visit which will also allow us to assess the absolute and relative change from baseline throughout the entire study.


Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00456885

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Principal Investigator: Eleftheria Maratos-Flier, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Eleftheria Maratos-Flier, Professor of Medicine, Beth Israel Deaconess Medical Center Identifier: NCT00456885     History of Changes
Other Study ID Numbers: 2006-p-000361
Study First Received: April 4, 2007
Last Updated: February 24, 2012

Keywords provided by Eleftheria Maratos-Flier, Beth Israel Deaconess Medical Center:
double blind
placebo controlled
weight loss
energy expenditure

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on August 21, 2017