Sanofi's Phase III clinical trial program for rimonabant consists of a dozen clinical trials that are part of two clinical development programs. A summary of results of these trials will be posted as information becomes available. To review the results, click on the name of the trial.

The Rimonabant In Obesity (RIO) Program

This Phase III program enrolled more than 6,600 overweight or obese patients worldwide in four clinical trials designed to explore the role of Acomplia in obesity management - weight loss/weight maintenance; prevention of weight regain after prior weight loss; and improvement of obesity-related risk factors such as diabetes and dyslipidemia.

The Studies with Rimonabant and Tobacco Use (STRATUS) Program

This program enrolled more than 6,500 patients worldwide in three clinical trials designed to explore the role of Acomplia in smoking cessation and long-term abstinence and prevention of weight gain upon smoking cessation.

While results of the first trial appeared quite promising, results of the other two trials were never disclosed. The U.S. Food and Drug Administration has informed Sanofi that another trial is required if rimomabant is to be considered as a smoking cessation aid.

Studies for Expanded Use of Rimonabant to Reduce Heart Attacks and Strokes, or Aid in Preventing and Treating Type 2 Diabetes

Five Phase IIIb clinical trials were initiated during 2005, and three more are being initiated in 2006, to assess the potential role of the Acomplia in reducing the risk of heart attacks or strokes in patients with abdominal obesity and other risk factors, and to explore use of Acomplia in preventing and treating Type 2 diabetes.

Phase IIIb Trials involving Cardiovascular Disease:

The CRESCENDO (Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes) trial, which got underway in December 2005, enrolled 17,000 participants, with researchers seeking to determine whether Acomplia reduces the number of patients who suffer a heart attack, stroke or cardiovascular death during the course of the trial.

The AUDITOR (Atherosclerosis Underlying Development Assessed By Intima-Media Thickness In Patients On Rimonabant) trial, which got underway in August 2005, has enrolled 600 participants, with researchers focusing on whether Acomplia retards the progression of atherosclerosis over a 24-month period.

The STRADIVARIUS (Strategy to Reduce Atherosclerosis Development Involving Administration of Rimonabant-The Intravascular Ultrasound Study) trial, which got underway in January 2005, enrolled 800 participants, with researchers also focusing on whether Acomplia retards the progression of atherosclerosis over an 18-month period.

The VICTORIA (Visceral Fat Reduction Assessed by CT-Scan on Rimonabant) trial, which got underway in March 2006, enrolled 250 participants in a 12-month study, with researchers focusing on how Acomplia affects visceral fat, liver fat content, weight, waist circumference, body composition, lipid profiles, glycemic, insulin and HbA1C levels and inflammatory markers when prescribed together with a reduced calorie diet for abdominally obese patients with metabolic syndrome.

The ADAGIO-Lipids (An International Study of Rimonabant in Dyslipidemia with AtheroGenic Risk in Abdominally Obese Patients) trial, a two-year study which got underway in June 2005, enrolled 740 participants, with researchers focusing on how Acomplia affects HDL cholesterol and triglycerides when prescribed together with a reduced calorie diet for abdominally obese patients with atherogenic dyslipidemia (characterized by low HDL and/or high triglycerides).

Phase IIIb Trials involving Type 2 Diabetes:

The SERENADE (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients) trial, a six-month study which began in March 2005, enrolled 281 participants, with researchers focusing on whether Acomplia aids glycemic control (as measured by HbA1C, an indicator of the level of blood glucose) in newly-diagnosed Type 2 diabetes patients not adequately controlled by diet.

The ARPEGGIO (A Multicenter, Randomized, Placebo-controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of rimonabant 20 mg/day on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin) trial, a two-year study that will begin later in 2006, will enroll 300 participants. Researchers will focus on whether Acomplia is useful as an add-on therapy therapy in patients with Type 2 diabetes who are treated with insulin, yet require further glycemic control
(as measured by HbA1c, an indicator of the level of blood glucose).

The RAPSODI (Rimonabant in Pre-Diabetic Subjects to Delay Onset of Type 2 Diabetes) trial, a two-year study that began in May 2006, has enrolled 2,100 participants, with researchers focusing on whether Acomplia helps prevent Type 2 diabetes in patients with pre-diabetes in the form of impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT).