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

NCT06937749 | Recruiting Phase 2

• 1 other identifier: CIBI362C201
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology

  Baseline, Week 60

Secondary Outcomes (26)

• Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology

  Baseline, Week 60

• Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology

  Baseline, Week 60

• Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology

  Baseline, Week 60

• Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology

  Baseline, Week 60

• Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology

  Baseline, Week 60

Study Arms (3)

IBI362 Low Dose

EXPERIMENTAL

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

Drug: IBI362

IBI362 High Dose

EXPERIMENTAL

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

Drug: IBI362

Placebo

PLACEBO COMPARATOR

Placebo,SC,once a week for 60 weeks

Drug: Placebo

Interventions

Placebo DRUG

Placebo administered subcutaneously (SC) once a week.

Placebo

IBI362 DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 High Dose; IBI362 Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

mazdutide

Central Study Contacts

Jie Wei

CONTACT

0512-69566088; jie.wei@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: July 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 22, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)