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
Phase of Trial: Phase III
Latest Information Update: 18 Oct 2017
At a glance
- Drugs Elafibranor (Primary)
- Indications Fibrosis; Non-alcoholic steatohepatitis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms RESOLVE-IT
- Sponsors Genfit
- 01 Jun 2017 According to a Genfit media release, the Data Safety Monitoring Board (DSMB) has reviewed safety data during 1-year pre-planned analysis and has recommended continuation of this trial without any modifications.
- 24 Apr 2017 According to a Genfit media release, enrolment of the first ~1000 patients to participate in the first phase of the trial is expected to be completed in Q1 2018.
- 08 Feb 2017 According to a GENFIT media release, subject to satisfactory clinical results obtained during the first stage of this study in a first group of approximately 1,000 patients, which company anticipates can be recruited by the Summer of 2017 and could lead to Subpart H conditional marketing authorization during the second half of 2019 or the first half of 2020.