Status:
RECRUITING
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Metabolic Dysfunction-associated Steatohepatitis (MASH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- Must be willing to participate in the study and provide written informed consent.
- Male or female, age 18 years or older at the time of signing informed consent
- Body mass Index (BMI) ≥25 kg/m²
- Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening
Exclusion
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- HbA1c\>10%
- History or current other forms of chronic liver disease other than MASH
- Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
- patients with HCV antibody positive.
- Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)
- Model for End-stage Liver Disease(MELD) \>12 or Child-Turcotte-Pugh(CTP) \>6
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 22 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06937749
Start Date
July 1 2025
End Date
July 22 2027
Last Update
November 20 2025
Active Locations (1)
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1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 100044