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RecruitingPhase 2NCT06937749

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)

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

165 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
  • HbA1c>10%
  • 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

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Interventions

DRUGPlacebo

Placebo administered subcutaneously (SC) once a week.

DRUGIBI362

IBI362 administered subcutaneously (SC) once a week.

Locations(1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

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NCT06937749