Obese Patients With or Without Comorbidities (RIO-North America)

Phase 3 Completed 3045 enrolled Sanofi

RandomizedParallel-groupDouble-blindPrevention

Summary

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

Timeline

Start: 2001-08
Primary completion: 2004-04
Completion: 2004-04

Outcome

Met primary endpoint

paper the 20 mg of rimonabant group produced greater mean (SEM) reductions in weight (-6.3 [0.2] kg vs -1.6 [0.2] kg; P<.001) PMID 16478899 ↗

paper those who continued to receive 20 mg of rimonabant maintained their weight loss PMID 16478899 ↗

Publications

Results Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rimonabant	Small molecule	5 mg	—
Subject	Rimonabant	Small molecule	20 mg	—