A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: liver
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥25 required; conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
- Interventions
- Placebo; IBI362
- Conditions
- Metabolic Dysfunction-associated Steatohepatitis (MASH)
- Phase and size
- Phase 2 · 165 participants
- Dates
- Start 2025-07-01
Primary completion 2026-04-30 - Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver HistologyBaseline, Week 60
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.