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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Dysfunction-associated Steatohepatitis (MASH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

Placebo

Placebo,SC,once a week for 60 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered subcutaneously (SC) once a week.

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

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

Interventions

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Placebo

Placebo administered subcutaneously (SC) once a week.

Intervention Type DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No