NCT06937749Active, not recruitingPhase 2
A Study of IBI362 in Participants With 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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 181 (actual)
- First submitted
- 7 Apr 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 23 Sept 2026
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06937749
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 181
- From 20 Jun 2025 to the primary completion date, 23 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- 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
Lab values
- HbA1c\>10%
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.