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

NCTNCT06937749Other idCIBI362C201

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 2
Enrollment: 165 participants (estimated)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design: Randomized · Triple masking
Countries: 1 country
China
Start: 1 Jul 2025
Primary completion: 30 Apr 2026 (estimated)
Completion: 22 Jul 2027 (estimated)
First posted: 22 Apr 2025
Last update posted: 20 Nov 2025
Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2025202620272028

Ph 2
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
NCT06937749
1 Jul 2025 to est. 22 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PlaceboDrug
IBI362Drug

Arms3

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 outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(20)

Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame · Baseline, Week 60
Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology
Time frame · Baseline, Week 60
Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame · Baseline, Week 60
Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame · Baseline, Week 60
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame · 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)
Time frame · 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
Time frame · Baseline, Week 4, Week 12, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Time frame · Baseline, Week 36, Week 60
Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in BMI [kg/m2]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Waist Circumference [cm]
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L
Time frame · Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]
Time frame · Baseline, Week 36, Week 60

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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