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

Phase 2 Completed 163 enrolled AstraZeneca Eli Lilly and Company · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2007-06
Primary completion: 2008-02
Completion: 2008-02

Outcome

Met primary endpoint

paper Exenatide-treated subjects lost 5.1 +/- 0.5 kg from baseline versus 1.6 +/- 0.5 kg with placebo (exenatide--placebo, P < 0.001). PMID 20332357 ↗

registry analysis (superiority or other test); Group A (Exenatide) vs Group B (Placebo); p <0.0001; Mixed Model Repeated Measures ANCOVA NCT00500370 ↗

Publications

Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	5 ug	Subcutaneous
Subject	Exenatide	Peptide	10 ug	Subcutaneous