Phase 2 Study to Evaluate the Safety and Effectiveness of IBI362 Treatment in Adults With Metabolic Dysfunction-Associated Steatohepatitis MASH

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IBI362 in adults with Metabolic Dysfunction-Associated Steatohepatitis MASH, a liver condition characterized by inflammation and fibrosis. This Phase 2 study is randomized, double-blind, and placebo-controlled, aiming to understand how well IBI362 works in improving liver health and related measures compared to a placebo. The trial includes a diverse group of participants diagnosed with MASH confirmed by liver biopsy. Participants will receive one of three treatments low-dose IBI362, high-dose IBI362, or placebo, administered once a week by subcutaneous injection. The study treatment involves dose escalation phases over the first 8 weeks and continues for a total of 60 weeks during the double-blind treatment period. This is preceded by an 8-week screening period to confirm eligibility and followed by a 4-week safety follow-up. During the study, participants will undergo various assessments including liver biopsies, imaging scans such as MRI to measure liver fat, and blood tests to monitor liver enzymes and metabolic markers. Patient-reported outcome questionnaires and physical measurements like body weight and waist circumference will also be collected. The main outcome measured is the resolution of MASH without worsening fibrosis after 60 weeks. The trial includes close monitoring of participant health and safety throughout the participation lasting about 72 weeks in total.

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)