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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

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.