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

Fatty Liver Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577148
• Other study ID #: EFC10144
• Secondary ID: EudraCT 2007-003
• Status: Terminated
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: June 12, 2009
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Drug:
• rimonabant (SR141716)
20 mg daily
• Placebo
daily administration

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Cove	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Chile	Sanofi-Aventis Administrative Office	Santiago
China	Sanofi-Aventis Administrative Office	Shangai
Colombia	Sanofi-Aventis Administrative Office	Santafe de Bogota
Croatia	Sanofi-Aventis Administrative Office	Zagreb
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
Italy	Sanofi-Aventis Administrative Office	Milan
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-Aventis Administrative Office	Mexico
Philippines	Sanofi-Aventis Administrative Office	Makati City
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Puerto Rico	Sanofi-Aventis Administrative Office	Puerto Rico
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Spain	Sanofi-Aventis Administrative Office	Barcelona
Switzerland	Sanofi-Aventis Administrative Office	Geneva
Taiwan	Sanofi-Aventis Administrative Office	Taipei
United Kingdom	Sanofi-Aventis Administrative Office	Guildford	Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Chile,  China,  Colombia,  Croatia,  France,  Germany,  Hungary,  Italy,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in histologic features of NASH from baseline to end of treatment liver biopsy		18 months	No
Secondary	Liver fibrosis, AST/ALT, serum hyaluronate		18 months	No