Efficacy and safety of Lanifibranor in NASH and liver fibrosis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
IRAS ID
303147
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Inventivia S.A.
Eudract number
2020-004986-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
140010, IND Number
Duration of Study in the UK
6 years, 9 months, 23 days
Research summary
The purpose of this study is to see if a medication not yet approved for marketing, named lanifibranor, will help in the treatment of non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis and how safe it is to use in people.
The study is planned to involve 2000 participants who have NASH and F2/F3 liver fibrosis. The study will have 3 groups of participants who will receive either lanifibranor (800 mg/day or 1200 mg/day) or matching placebo.
Participants will be in the study and receive treatment for a maximum of 5 to 7 years. This will involve a maximum of 22 visits, approximately every 12 weeks or every 24 weeks depending on the study period, to the study site. There would also be 13 telephone appointments.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0739
Date of REC Opinion
18 Nov 2021
REC opinion
Further Information Favourable Opinion