A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis
ID Number 16-0683Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to determine the efficacy of Elafibranor compared to placebo in the treatment of nonalcoholic steatohepatitis (NASH). A placebo looks the same as the study treatment (same shape, same look), except that it contains no active substance. The second purpose is to determine if the study treatment, Elafibranor, reduces the number of NASH patients that will develop further complications from NASH such as liver cirrhosis, liver decompensation events (for example, hepatic encephalopathy or variceal bleeding), liver cancer, liver transplant and death compared to placebo after long term treatment.
Subjects may be eligible to participate if they have been diagnosed with NASH or are at a high risk for developing it. There is a 2 out of 3 chance of receiving the study drug, and 1 in 3 chance of receiving the placebo.
Participation in this study is expected to last 6 years. The treatment period is 72-weeks and includes the screening visit. After the treatment period, visits will occur every 6 months for the remainder of the study.
A maximum of 4 liver biopsies will be performed during the study:
- once during the screening period (This biopsy is only required if the subject has not already had a liver biopsy in the 6 months prior to the study entry visit.),
- once after the first 72 weeks of treatment,
- once after approximately 4 years of study treatment, and
- if, during the study, the doctor suspects that the subject has progressed to cirrhosis, an additional liver biopsy may be required.
The total number of subjects expected to participate in this study is 2,200 globally and 10 at this site.
Recruiting Patients: Yes