A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

NCT00420589 ↗

Phase 3 Terminated 1000 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

Timeline

Start: 2006-10
Primary completion: 2008-02
Completion: 2008-11

Outcome

Met primary endpoint

Stopped: “The overall profile does not support development for obesity”

paper was +1.7 kg for placebo, compared with -0.1, -0.6, and -1.2 kg for the taranabant 0.5, 1, and 2 mg doses, respectively PMID 20379151 ↗

paper all P values ≤ 0.007 vs. placebo PMID 20379151 ↗

Publications

Results Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	taranabant	Unknown	0.5 mg	—
Subject	taranabant	Unknown	1 mg	—
Subject	taranabant	Unknown	2 mg	—