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.

Study Overview

• Status: Terminated
• Conditions: Fatty Liver
• Intervention / Treatment: Drug: Rimonabant; Drug: Placebo (for Rimonabant)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Sanofi-Aventis Administrative Office
• Australia
  • New South Wales
    • Cove, New South Wales, Australia
      • Sanofi-Aventis Administrative Office
• Belgium
  • Diegem, Belgium
    • Sanofi-Aventis Administrative Office
• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office
• Chile
  • Santiago, Chile
    • Sanofi-Aventis Administrative Office
• China
  • Shangai, China
    • Sanofi-Aventis Administrative Office
• Colombia
  • Santafe de Bogota, Colombia
    • Sanofi-Aventis Administrative Office
• Croatia
  • Zagreb, Croatia
    • Sanofi-Aventis Administrative Office
• France
  • Paris, France
    • Sanofi-Aventis Administrative Office
• Germany
  • Berlin, Germany
    • Sanofi-Aventis Administrative Office
• Hungary
  • Budapest, Hungary
    • Sanofi-Aventis Administrative Office
• Italy
  • Milan, Italy
    • Sanofi-Aventis Administrative Office
• Malaysia
  • Kuala Lumpur, Malaysia
    • Sanofi-Aventis Administrative Office
• Mexico
  • Mexico, Mexico
    • Sanofi-Aventis Administrative Office
• Philippines
  • Makati City, Philippines
    • Sanofi-Aventis Administrative Office
• Poland
  • Warszawa, Poland
    • Sanofi-Aventis Administrative Office
• Portugal
  • Porto Salvo, Portugal
    • Sanofi-Aventis Administrative Office
• Puerto Rico
  • Puerto Rico, Puerto Rico
    • Sanofi-Aventis Administrative Office
• Romania
  • Bucuresti, Romania
    • Sanofi-Aventis Administrative Office
• Spain
  • Barcelona, Spain
    • Sanofi-Aventis Administrative Office
• Switzerland
  • Geneva, Switzerland
    • Sanofi-Aventis Administrative Office
• Taiwan
  • Taipei, Taiwan
    • Sanofi-Aventis Administrative Office
• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom
      • Sanofi-Aventis Administrative Office
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rimonabant; Rimonabant 20 mg once daily.	Drug: Rimonabant; Tablet, oral administration; Other Names: Acomplia; SR141716
Placebo Comparator: Placebo; Placebo (for Rimonabant) once daily.	Drug: Placebo (for Rimonabant); Tablet, oral administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: NASH; chronic liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Cannabinoid Receptor Modulators; Cannabinoid Receptor Antagonists; Rimonabant
• Other Study ID Numbers: EFC10144; 2007-003013-14 (EudraCT Number)