Phase 4
Completed N=182
Weight Loss With Exenatide Treatment
Source: ClinicalTrials.gov NCT01590433 ↗Enrolled (actual)
182
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Change in Body Weight — 6.5; 7.5 percentage weight loss — p=<0.05
◆ Published Evidence
Established
23citations · ~5 / year
Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women.
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.
Linked Publications
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Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
6.5; 7.5 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01590433) 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.