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

Phase 2

Not yet recruiting

• Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
• Interventions: Drug: IBI362; Drug: Placebo

• Registration Number: NCT06937749
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-30
• Primary Completion: 2026-04-30
• Study Completion: 2027-07-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI362 Low Dose	IBI362	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
IBI362 High Dose	IBI362	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	Placebo	Placebo,SC,once a week for 60 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology	Baseline, Week 60

Secondary Outcome Measures

Name	Time	Method
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
Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)	Baseline, Week 4, Week 12, Week 36, Week 60
Percentage of participants with at least 30%, 50% and 70% relative reduction in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) From Baseline	Baseline, Week 4, Week 12, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]	Baseline, Week 36, Week 60
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]	Baseline, Week 36, Week 60
Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction	Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in BMI [kg/m2]	Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Waist Circumference [cm]	Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L	Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]	Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]	Baseline, Week 36, Week 60
Change from Baseline in Homeostasis Model Assessment IR	Baseline, Week 36, Week 60
Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)	Baseline, Week 36, Week 60	The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)
Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)	Baseline, Week 36, Week 60	NASH-CHECK scores range from 0 to 10, with higher scores indicating worse symptoms/HRQOL
Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）	Baseline, Week 36, Week 60	6-point Patient Global Impression of Severity of NASH symptoms (PGIS; 7-day recall period; responses ranging from "no symptoms" to "very severe").

Trial Locations

Locations (1)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China