Facilitated By

San Antonio Medical Foundation

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study To Evaluate The Efficacy And Safety Of Elafibranor In Patients With Nonalcoholic Steatohepatitis (Nash) And Fibrosis

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

Randomized, double-blind, parallel groups (placebo or elafibranor [GFT505]) placebo-controlled study, evaluating the efficacy and safety of elafibranor 120 mg QD versus placebo in an adult NASH population with fibrosis. The first double-blind 72-week treatment period will assess the efficacy and safety of elafibranor on the resolution of NASH without worsening of fibrosis at the intermediate efficacy analysis, followed by a Long-term Treatment Period to assess efficacy on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (all-cause mortality, progression to histological cirrhosis, and the full list of portal

Clinical Care
Infectious Disease
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