Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-11-20
165
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and provide written informed consent
- Male or female aged 18 years or older
- Body mass index (BMI) of 25 kg/m² or higher
- Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) confirmed by biopsy showing NAS ≥4 with at least 1 point in steatosis, inflammation, and ballooning each
- Fibrosis stage F2 or F3 confirmed by biopsy within 3 months prior to screening or during screening period
You will not qualify if you...
- Allergy to the study drug or similar drugs
- HbA1c greater than 10%
- History or current presence of other chronic liver diseases besides MASH
- Positive Hepatitis B surface antigen (HBsAg); positive Hepatitis B core antibody (HBcAb) only if HBV DNA test is negative at screening
- Positive Hepatitis C virus antibody
- Positive HIV antibody or syphilis-specific antibodies (non-specific antibody negative allowed)
- Model for End-stage Liver Disease (MELD) score greater than 12 or Child-Turcotte-Pugh (CTP) score greater than 6
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 weeks
Participants receive weekly subcutaneous injections of IBI362 or placebo for up to 60 weeks, with dose levels varying by group.
Weekly visits for up to 60 weeks
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jie Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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