Clinical Trials


NATIVE Phase III Trial

 

We are currently evaluating lanifibranor in NATiV3 (NASH lanifibranor Phase 3 trial), a two-part randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis.

The initiation of the NATiV3 trial follows the publication of positive results from the NATIVE Phase IIb clinical trial with lanifibranor in NASH in June 2020 as well as its designation as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in October 2020.

Part 1 of NATiV3 will assess the effect of lanifibranor (800mg/daily and 1200mg/daily) compared to placebo on the primary composite endpoint of NASH resolution and improvement of fibrosis of at least one stage.

The key secondary endpoints include NASH resolution without worsening of fibrosis as well as improvement of fibrosis and no worsening of NASH.

Part 2 will follow the 72-week histology analysis and will assess the effect of lanifibranor (800mg/daily and 1200mg/daily) compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, and all-cause death.

In addition to the key primary and secondary endpoints, the impact of lanifibranor on biomarkers of metabolic health will be evaluated as part of the trial. The occurrence of Major Adverse Cardiovascular Events, such as myocardial infarction and stroke, will also be evaluated as an exploratory efficacy endpoint and to establish the safety profile of lanifibranor.

The last visit of the last patient enrolled in part 1 of the NATiV3 Phase III clinical trial is planned for the first half of 2024, with the publication of the headline results of the first part of the trial expected for the second half of 2024.