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).

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577148

Enrollment

Registered

2007-12-19

Start date

2008-02-29

Completion date

2009-02-28

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

NASH, chronic liver disease

Brief summary

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.

Detailed description

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

Interventions

DRUGRimonabant

Tablet, oral administration

DRUGPlacebo (for Rimonabant)

Tablet, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

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, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026