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NCT Number: NCT06937749

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

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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Key information

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Lai Wei

CONTACT

[email protected]

010-51668930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Placebo

Drug

Placebo administered subcutaneously (SC) once a week.

IBI362

Drug

IBI362 administered subcutaneously (SC) once a week.

Primary outcomes

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

    Time frame: Baseline, Week 60

Secondary outcomes

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline, Week 60

  6. 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

  7. 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

  8. Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]

    Time frame: Baseline, Week 36, Week 60

  9. Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]

    Time frame: Baseline, Week 36, Week 60

  10. Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]

    Time frame: Baseline, Week 36, Week 60

  11. Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]

    Time frame: Baseline, Week 36, Week 60

  12. Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]

    Time frame: Baseline, Week 36, Week 60

  13. Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]

    Time frame: Baseline, Week 36, Week 60

  14. Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]

    Time frame: Baseline, Week 36, Week 60

  15. Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]

    Time frame: Baseline, Week 36, Week 60

  16. Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction

    Time frame: Baseline, Week 36, Week 60

  17. Mean Absolute Change from Baseline in BMI [kg/m2]

    Time frame: Baseline, Week 36, Week 60

  18. Mean Absolute Change from Baseline in Waist Circumference [cm]

    Time frame: Baseline, Week 36, Week 60

  19. Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L

    Time frame: Baseline, Week 36, Week 60

  20. Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]

    Time frame: Baseline, Week 36, Week 60

  21. Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]

    Time frame: Baseline, Week 36, Week 60

  22. Change from Baseline in Homeostasis Model Assessment IR

    Time frame: Baseline, Week 36, Week 60

  23. Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)

    Time frame: 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)

  24. Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)

    Time frame: Baseline, Week 36, Week 60

    NASH-CHECK scores range from 0 to 10, with higher scores indicating worse symptoms/HRQOL

  25. Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）

    Time frame: 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").

  26. The proportion of subjects with at least a 25% improvement in liver stiffness measurement (LSM) relative to baseline based on FibroScan and FibroTouch measurements, and the proportion of subjects with at least a 30% improvement in controlled attenuation

    Time frame: Baseline, Week 36, Week 60

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Wei

CONTACT

[email protected]

0512-69566088

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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