Actively Recruiting
A Study 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
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
CONDITIONS
Official 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 at consent
- Body mass index (BMI) of 25 kg/m² or higher
- Diagnosed with Metabolic Dysfunction-associated Steatohepatitis (MASH) with a Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) of 4 or more, including at least 1 point each in steatosis, inflammation, and ballooning
- Fibrosis stage F2 or F3 confirmed by biopsy during screening or within 3 months prior to screening
You will not qualify if you...
- Allergy to components in the study drug or similar drugs
- HbA1c greater than 10%
- History or current other chronic liver diseases besides MASH
- Positive Hepatitis B surface antigen (HBsAg); positive HBcAb only eligible if HBV DNA test is negative at screening
- Positive Hepatitis C antibody
- Positive HIV antibody or syphilis-specific antibodies (non-specific antibody turned negative is eligible)
- 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
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jie Wei
CONTACT
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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