RESOLVE-IT: A Study of Elafibranor in Patients with NASH and fibrosis
Research type
Research Study
Full title
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
IRAS ID
204478
Contact name
Quentin Anstee
Contact email
Sponsor organisation
Genfit
Eudract number
2015-005385-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 1 days
Research summary
Research Summary
Nonalcoholic steatohepatitis (NASH) is a disorder that falls as a subgroup of Nonalcoholic fatty liver disease (NAFLD) and occurs when there is excessive fat build-up in the liver causing damage to the cells and inflammation with or without scarring (fibrosis).
Eventually, progression of the disease in the Liver will lead to advanced fibrosis, cirrhosis and other liver complications that include liver failure and liver cancer.The purpose of this study is to examine how safe and effective Elafibranor is in the treatment of NASH. Patients who are found to be eligible for the study will be consented and they will follow an initial treatment phase of 72 weeks with either Elafibranor or a Placebo and then to continue into a long term treatment phase for a total of approximately 72 months.
Participants will be randomised to receive either 120mg Elafibranor or placebo in a 2:1 ratio (Elafibranor:placebo) in a blinded manner. Treatment groups will be balanced on entry depending on 3 factors: whether they have type 2 diabetes; Gender and their Fibrosis stage. Both elafibranor and the placebo will be provided as a white to off-white round coated tablet with no printed inscription.Patients will receive the drug they will require at every study visit once they are randomised onto the study and instructed to take one tablet per day orally before breakfast with a glass of water each morning. During the first treatment phase visits will be every 12 weeks and Clinical and biological evaluation will be performed during the First Treatment Period.
This is a multicentre, multinational, randomised, double-blind study comparing the efficacy and safety of Elafibranor to a placebo in patients with NASH
Study Sites: This study is to be conducted at approximately 220 study sites worldwide.Summary of Research
: A total of 265 sites were initiated in 25 countries during the study between 10 March 2016 and 28 October 2020 to evaluate the efficacy of the study drug elafibranor versus placebo on the resolution of patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis.Elafibranor was generally safe and well tolerated, with similar occurrences of Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest compared with placebo. The safety data from this study are supportive of ongoing clinical investigation.
However, as the results did not demonstrate a statistically significant difference between elafibranor and placebo treatment arms on the primary efficacy endpoint, and the very low probability to obtain positive results on the long-term clinical outcomes if patients were to continue in the trial, GENFIT made the decision to prematurely terminate the study due to lack of efficacy but not due to safety concerns.
As a consequence of Sponsor’s decision to terminate the trial prematurely, the primary study objective to evaluate the long-term efficacy of elafibranor 120 mg versus placebo on clinical outcomes was not performed.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0147
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion