A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.

Key facts

Study ID

NCT00500370

Run by

AstraZeneca

People needed

163

Starts

2007-06-01

Expected to finish

2008-02-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a Body Mass Index (BMI) >= 30kg/m\^2

You may not qualify if…

• Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
• Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
• Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
• Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
• Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
• Are actively participating in, or have participated in a formal weight loss program within the last 3 months
• Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
• Have been treated with any anti-diabetic medications within 3 months of screening
• Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
• Have had bariatric surgery
• Have had an organ transplant

Where it is running

• Research Site — Peoria, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Santa Ana, California, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Topeka, Kansas, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Goose Creek, South Carolina, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Dallas, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Renton, Washington, United States
• Research Site — Ponce, Puerto Rico
• Research Site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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