NCT06937749 A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
| NCT ID | NCT06937749 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Metabolic Dysfunction-associated Steatohepatitis (MASH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 165 participants in total. It began in 2025-07-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06937749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metabolic Dysfunction-associated Steatohepatitis (MASH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06937749 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06937749 currently recruiting?
Yes, NCT06937749 is actively recruiting participants. Contact the research team at jie.wei@innoventbio.com for enrollment information.
Where is the NCT06937749 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06937749 clinical trial?
NCT06937749 is sponsored by Innovent Biologics (Suzhou) Co. Ltd.. The trial plans to enroll 165 participants.