LEGEND 337HNAS21016
Research type
Research Study
Full title
A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of Lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with Non- alcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM)
IRAS ID
1005760
Contact name
Frédéric Cren
Contact email
Sponsor organisation
Inventiva S.A.
Eudract number
2021-005057-87
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine if experimental Investigational Medicinal Product (IMP), lanifibranor is safe and effective when used alone or in combination with an already marketed medicine named empagliflozin in patients with non-alcoholic steatohepatitis (NASH) and have type 2 diabetes mellitus (T2DM).
NASH is a liver disease associated with inflammation and liver cell injury. This condition may lead to advanced scarring of the liver called fibrosis and even up to cirrhosis (the most advanced stage of the disease). In T2DM, insulin, (the major hormone that controls blood glucose) no longer functions optimally (‘insulin resistance’). This insulin resistance causes not only T2DM but can also be associated with the development of NASH. Currently, there is no medication approved for the treatment of NASH.
If participants meet the eligibility criteria for the study, they will be randomly assigned to 1 of the 3 treatment groups. One of these groups will be a placebo group where the medication is not expected to have any effect. Participants from the two other groups will receive an active medication, either lanifibranor or lanfibranor plus empagliflozin. The study will last approximately 34 weeks including a 6 week screening period, a treatment period of 24 weeks, and 4 weeks at the end for follow up. The study will involve taking clinical laboratory samples from participants as well as liver imaging using MRI and ultrasounds.
This study is organised and funded by Sponsor Inventiva S.A, and is planning to involve 63 patients in the UK, USA, Netherlands, France and Belgium.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0505
Date of REC Opinion
1 Sep 2022
REC opinion
Further Information Favourable Opinion