IBI362 for Metabolic Dysfunction‑Associated Steatohepatitis (MASH)
A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This trial will test whether two doses of the drug IBI362 are safe and can improve liver disease in adults with biopsy‑proven MASH (fibrosis stage F2–F3).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06937749 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double‑blind, placebo‑controlled Phase 2 trial comparing low‑dose IBI362, high‑dose IBI362, and placebo in adults with biopsy‑proven MASH. Eligible participants have BMI ≥25 kg/m² and a NAFLD Activity Score ≥4 with fibrosis stage F2 or F3. The timeline includes an 8‑week screening period, a 60‑week blinded treatment period, and a 4‑week follow‑up. The study will track liver histology and safety outcomes over the treatment period.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI ≥25 kg/m² and biopsy‑proven MASH with NAS ≥4 and fibrosis stage F2 or F3 are ideal candidates.
Not a fit: People with other chronic liver diseases, positive HBsAg, very poor glucose control (HbA1c >10%), or fibrosis outside the F2–F3 range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, IBI362 could reduce liver inflammation and fibrosis in people with MASH and offer a new treatment option.
How similar studies have performed: Other metabolic and hormone‑targeting agents have shown encouraging signals in NASH/MASH early trials, but IBI362's effects specifically remain to be demonstrated in controlled studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jie Wei
- Email: jie.wei@innoventbio.com
- Phone: 0512-69566088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.