A Randomized, Open-Label, Single-Center Study to Evaluate the Bioequivalence of Lanifibranor in Patients with Non-alcoholic Steatohepatitis

The primary objective of this study is to evaluate the bioequivalence of lanifibranor in patients with non-alcoholic steatohepatitis. Establishing bioequivalence is clinically relevant to ensure that the test formulation produces a comparable rate and extent of absorption to the reference product, maintaining therapeutic consistency.

The sponsor did not provide the total number of participants for this study. The investigation involves healthy volunteers within the specified age range. The study population includes both males and females, including vulnerable populations. Participants are assessed in relation to non-alcoholic steatohepatitis.

This is a Phase 2, randomised, open-label, single-centre study designed to evaluate the bioequivalence of lanifibranor in patients with non-alcoholic steatohepatitis. The research methodology involves a structured sequence of study visits, beginning with a screening visit to assess eligibility. Subsequent follow-up visits are conducted to monitor the intervention, concluding with an end-of-study visit. The expected duration of participant involvement is determined by the clinical protocol, although conditions may lead to early termination from the study. The estimated recruitment period for this trial is from February 2026 to April 2026.

Efficacy in the treatment of non-alcoholic steatohepatitis will be evaluated according to the study protocol. The assessment involves specific parameters to measure clinical response and disease modification.