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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Information provided by (Responsible Party):
Sanofi Identifier:
First received: December 18, 2007
Last updated: April 18, 2016
Last verified: April 2016

December 18, 2007
April 18, 2016
January 2008
February 2009   (Final data collection date for primary outcome measure)
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [ Time Frame: Baseline to 24 months ]
Change in histologic features of NASH from baseline to end of treatment liver biopsy [ Time Frame: 24 or more months ]
Complete list of historical versions of study NCT00576667 on Archive Site
  • Change from baseline in hepatic fibrosis score [ Time Frame: Baseline to 24 months ]
  • Change from baseline in serum hyaluronate (HA) [ Time Frame: Baseline to 24 months ]
  • Change from baseline in hepatic transaminases (AST/ALT) [ Time Frame: Baseline to 24 months ]
Liver fibrosis, AST/ALT, serum hyaluronate [ Time Frame: 24 or more months ]
Not Provided
Not Provided
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-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).
The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fatty Liver
  • Drug: Rimonabant
    Tablet, oral administration
    Other Names:
    • SR141716
    • Acomplia
  • Drug: Placebo (for Rimonabant)
    Tablet, oral administration
  • Experimental: Rimonabant
    Rimonabant 20 mg once daily.
    Intervention: Drug: Rimonabant
  • Placebo Comparator: Placebo
    Placebo (for Rimonabant) once daily.
    Intervention: Drug: Placebo (for Rimonabant)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with diagnosis of NASH

Exclusion Criteria:

  • Excessive alcohol use
  • Presence of 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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
Bulgaria,   Canada
2007-003013-14 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Study Director: ICD CSD Sanofi
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP