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

Phase 3

Terminated

• Conditions: Fatty Liver
• Interventions: Drug: Placebo (for Rimonabant); Drug: Rimonabant

• Registration Number: NCT00577148
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Start: 2008-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-18
• Disposition First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Disposition First Posted: 2016-05-18
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Rimonabant)	Placebo (for Rimonabant) once daily.
Rimonabant	Rimonabant	Rimonabant 20 mg once daily.

Primary Outcome Measures

Name	Time	Method
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)	Baseline to 18 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in hepatic fibrosis score	Baseline to 18 months
Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT)	Baseline to 18 months

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford, Surrey, United Kingdom