An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
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ClinicalTrials.gov Identifier: NCT00576667 |
Recruitment Status
:
Terminated
(Company decision taken in light of demands by certain national health authorities)
First Posted
: December 19, 2007
Last Update Posted
: May 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fatty Liver | Drug: Rimonabant Drug: Placebo (for Rimonabant) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 165 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH) |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Rimonabant
Rimonabant 20 mg once daily.
|
Drug: Rimonabant
Tablet, oral administration
Other Names:
|
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily.
|
Drug: Placebo (for Rimonabant)
Tablet, oral administration
|
- Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [ Time Frame: Baseline to 24 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576667

Study Director: | ICD CSD | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00576667 History of Changes |
Other Study ID Numbers: |
EFC10143 2007-003013-14 ( EudraCT Number ) |
First Posted: | December 19, 2007 Key Record Dates |
Last Update Posted: | May 18, 2016 |
Last Verified: | April 2016 |
Keywords provided by Sanofi:
NASH chronic liver disease |
Additional relevant MeSH terms:
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases Rimonabant Cannabinoid Receptor Antagonists |
Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |