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)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00576667

First Posted: December 19, 2007

Last Update Posted: May 18, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Sanofi

Purpose

The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).

Condition	Intervention	Phase
Fatty Liver	Drug: Rimonabant Drug: Placebo (for Rimonabant)	Phase 3


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: non-alcoholic fatty liver disease

MedlinePlus related topics: Liver Diseases

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures:

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 ]


Enrollment:	165
Study Start Date:	January 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rimonabant Rimonabant 20 mg once daily.	Drug: Rimonabant Tablet, oral administration Other Names: SR141716 Acomplia
Placebo Comparator: Placebo Placebo (for Rimonabant) once daily.	Drug: Placebo (for Rimonabant) Tablet, oral administration

Detailed Description:

The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Show 24 Study Locations

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	ICD CSD	Sanofi

More Information


Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00576667 History of Changes
Other Study ID Numbers:	EFC10143 2007-003013-14 ( EudraCT Number )
First Submitted:	December 18, 2007
First Posted:	December 19, 2007
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

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