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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
165
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 60
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]
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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
Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]
Time frame: Baseline, Week 36, Week 60
Change from Baseline in Homeostasis Model Assessment IR
Time frame: Baseline, Week 36, Week 60
Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)
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)
Time frame: Baseline, Week 36, Week 60
Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)
NASH-CHECK scores range from 0 to 10, with higher scores indicating worse symptoms/HRQOL
Time frame: Baseline, Week 36, Week 60
Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）
6-point Patient Global Impression of Severity of NASH symptoms (PGIS; 7-day recall period; responses ranging from "no symptoms" to "very severe").
Time frame: Baseline, Week 36, Week 60
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