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A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Lead sponsor
Asset
Mazdutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
1
Enrollment
165
estimated
Study population
MASH / NAFLD / liver fibrosis, Obesity / overweight
Key I/E criterion
•BMI ≥25
Primary endpoint
•MASH resolution, no fibrosis worsening
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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
Endpoints (27)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpointsMean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Time frame:Baseline, Week 36, Week 60
Body weight, absolute change (kg)
change from baseline, improvement
Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction
Time frame:Baseline, Week 36, Week 60
≥15% weight-loss responders
threshold achievement, improvement
Mean Absolute Change from Baseline in BMI [kg/m2]
Time frame:Baseline, Week 36, Week 60
BMI, change
change from baseline, improvement
Mean Absolute Change from Baseline in Waist Circumference [cm]
Time frame:Baseline, Week 36, Week 60
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsMean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L
Time frame:Baseline, Week 36, Week 60
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]
Time frame:Baseline, Week 36, Week 60
change from baseline, improvement
Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]
Time frame:Baseline, Week 36, Week 60
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from Baseline in Homeostasis Model Assessment IR
Time frame:Baseline, Week 36, Week 60
HOMA-IR (insulin sensitivity)
change from baseline, improvement
MASH / liver
12 endpointsPercentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Time frame:Baseline, Week 60
MASH resolution, no fibrosis worsening
categorical status, improvement
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame:Baseline, Week 60
Fibrosis ≥1-stage improvement, no MASH worsening
threshold achievement, improvement
Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology
Time frame:Baseline, Week 60
categorical status, improvement
Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame:Baseline, Week 60
Fibrosis ≥1-stage improvement, no MASH worsening
threshold achievement, improvement
Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame:Baseline, Week 60
MASH resolution + fibrosis improvement
categorical status, improvement
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame:Baseline, Week 60
Fibrosis ≥1-stage improvement, no MASH worsening
threshold achievement, improvement
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
Liver fat content, change
change from baseline, improvement
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
MRI-PDFF ≥30% responders
threshold achievement, improvement
Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]
Time frame:Baseline, Week 36, Week 60
AST, change
change from baseline, improvement
LOINC 1920-8
Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]
Time frame:Baseline, Week 36, Week 60
ALT, change
change from baseline, improvement
LOINC 1742-6
Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]
Time frame:Baseline, Week 36, Week 60
γ-GT, change
change from baseline, improvement
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
threshold achievement, improvement
componentsLiver stiffness (VCTE), change, Liver fat content, change
Cardiometabolic biomarkers
4 endpointsMean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Time frame:Baseline, Week 36, Week 60
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Time frame:Baseline, Week 36, Week 60
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Time frame:Baseline, Week 36, Week 60
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Time frame:Baseline, Week 36, Week 60
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Patient-reported / QoL
3 endpointsChanges from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)
Time frame:Baseline, Week 36, Week 60
SF-36 total
change from baseline, improvement
Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)
Time frame:Baseline, Week 36, Week 60
change from baseline, improvement
Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）
Time frame:Baseline, Week 36, Week 60
PGI, change
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.