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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06937749
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metabolic Dysfunction-associated Steatohepatitis (MASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo administered subcutaneously (SC) once a week.
  • IBI362 — DRUG
    IBI362 administered subcutaneously (SC) once a week.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
Jul 22, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI362 Low Dose
    Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for 52 weeks
  • Experimental: IBI362 High Dose
    Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for for 4 weeks; Dose level 4,SC,once a week for 48 weeks
  • Placebo Comparator: Placebo
    Placebo,SC,once a week for 60 weeks

Primary Outcome Measure

Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology [ Time Frame: Baseline, Week 60 ]

Central Contacts

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