A Phase 3 interventional study of Rimonabant and Placebo (for Rimonabant) in Fatty Liver, sponsored by Sanofi. Terminated at 24 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-18.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 89 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Rimonabant 20 mg once daily.
Drug: Rimonabant
Placebo (for Rimonabant) once daily.
Drug: Placebo (for Rimonabant)
Tablet, oral administration
Also known as: SR141716, Acomplia
Tablet, oral administration
Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)
Time frame: Baseline to 18 months
Change from baseline in hepatic fibrosis score
Time frame: Baseline to 18 months
Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT)
Time frame: Baseline to 18 months
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi