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

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00577148
First received: December 18, 2007
Last updated: June 12, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Fatty Liver
Drug: rimonabant (SR141716)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in histologic features of NASH from baseline to end of treatment liver biopsy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver fibrosis, AST/ALT, serum hyaluronate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rimonabant (SR141716)
20 mg daily
Placebo Comparator: 2 Drug: Placebo
daily administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577148

  Show 24 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00577148     History of Changes
Other Study ID Numbers: EFC10144, EudraCT 2007-003013-14
Study First Received: December 18, 2007
Last Updated: June 12, 2009
Health Authority: Mexico: Ministry of Health

Keywords provided by Sanofi:
NASH
chronic liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014