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A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

NCT06937749 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Metabolic Dysfunction-associated Steatohepatitis (MASH)

Interventions

DRUG

Placebo

Placebo administered subcutaneously (SC) once a week.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-04-30
Completion
2027-07-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06937749 on ClinicalTrials.gov