Weight Loss With Exenatide Treatment
Completed · Phase 4 · Has a placebo group
Conditions studied: Obesity
In brief
The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment. Hypothesis: The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. By identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.
Key facts
- Study ID
- NCT01590433
- Run by
- Jody Dushay
- People needed
- 249
- Starts
- 2012-03-01
- Expected to finish
- 2019-01-01
- Last updated by the study team
- 2021-06-23
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Females age 18-70
- BMI 28-48 kg/m\^2
- Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
- Ability to give informed consent and follow verbal and written instructions in English.
You may not qualify if…
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Unstable heart disease as evidenced by ongoing angina
- Congestive heart failure
- Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
- Tobacco, marijuana, cocaine, or intravenous drug use
- Shift workers (night shift or alternating day/night shifts)
- Gastroparesis
- Inflammatory bowel disease or irritable bowel syndrome
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression requiring hospitalization or diagnosis of psychosis
- Renal insufficiency (eGFR less than 50)
- Transaminases greater than 2 times above the normal range
- Pregnancy within 6 months of the screening visit
- Lactation
- Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
- History of an eating disorder (anorexia, bulimia or laxative abuse)
- Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss
- History of gastric bypass surgery or gastric stapling
- Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit
- Previous treatment with exenatide
- Discretion of the PI
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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