An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.

The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Inclusion Criteria:

• Patients with Type 2 diabetes mellitus and a diagnosis of NASH

Exclusion Criteria:

• Excessive alcohol use
• Presence of Type 1 diabetes mellitus
• Other chronic liver disease
• Previous or current hepatocellular carcinoma
• Use of medication known to cause steatosis
• Previous bariatric surgery
• Pregnancy or breastfeeding
• Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.