Placebo: Placebo administered subcutaneously (SC) once a week.
IBI362: IBI362 administered subcutaneously (SC) once a week.
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. HbA1c\>10%
3. History or current other forms of chronic liver disease other than MASH
4. Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
5. patients with HCV antibody positive.
6. Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)
7. Model for End-stage Liver Disease(MELD) \>12 or Child-Turcotte-Pugh(CTP) \>6
Primary outcome measure(s)
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology — Baseline, Week 60
Trial sites (1)
Facility
City
Region
Status
Beijing Tsinghua Changgung Hospital
Beijing
Beijing Municipality
Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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