Clinical trial NCT06937749: A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Official 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
timeFrame: Baseline, Week 60
Secondary outcomes:
measure: Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
timeFrame: Baseline, Week 60
measure: Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology
timeFrame: Baseline, Week 60
measure: Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
timeFrame: Baseline, Week 60
measure: Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
timeFrame: Baseline, Week 60
measure: Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
timeFrame: Baseline, Week 60
measure: Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
timeFrame: Baseline, Week 4, Week 12, Week 36, Week 60
measure: 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
timeFrame: Baseline, Week 4, Week 12, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
timeFrame: Baseline, Week 36, Week 60
measure: Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change from Baseline in BMI [kg/m2]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change from Baseline in Waist Circumference [cm]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]
timeFrame: Baseline, Week 36, Week 60
measure: Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]
timeFrame: Baseline, Week 36, Week 60
measure: Change from Baseline in Homeostasis Model Assessment IR
timeFrame: Baseline, Week 36, Week 60
measure: Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)
timeFrame: Baseline, Week 36, Week 60
measure: Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)
timeFrame: Baseline, Week 36, Week 60
measure: Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）
timeFrame: Baseline, Week 36, Week 60
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
References: