Title: A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3)
Associated condition: NASH
Status: Currently enrolling
Brief summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3.
Primary objectives:
Part 1: To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology.
Part 2: To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.
Estimated length of study: Participants will be expected to be in the study for a total of 72 weeks.
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
