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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Fatty Liver

Treatments: Drug: Placebo (for Rimonabant); Drug: Rimonabant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576667

2007-003013-14 (EudraCT Number)

EFC10143

Details and patient eligibility

About

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

Full description

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

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 2 patient groups, including a placebo group

Rimonabant

Experimental group

Description:

Rimonabant 20 mg once daily.

Treatment:

Drug: Rimonabant

Placebo

Placebo Comparator group

Description:

Placebo (for Rimonabant) once daily.

Treatment:

Drug: Placebo (for Rimonabant)