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

Innovent Biologics

Status and phase: Begins enrollment this month; Phase 2

Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)

Treatments: Drug: Placebo; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT06937749

CIBI362C201

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 3 patient groups, including a placebo group

IBI362 Low Dose

Experimental group

Description:

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

Treatment:

Drug: IBI362

IBI362 High Dose

Experimental group

Description:

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

Treatment:

Drug: IBI362

Placebo

Placebo Comparator group

Description:

Placebo,SC,once a week for 60 weeks

Treatment:

Drug: Placebo