Weight Loss With Exenatide Treatment

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Eleftheria Maratos-Flier; Jody Dushay
• Collaborator: AstraZeneca
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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