Recruiting NCT06937749
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, IBI362.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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
- Drug Placebo
Placebo administered subcutaneously (SC) once a week. - Drug IBI362
IBI362 administered subcutaneously (SC) once a week.
Primary outcome measures
- Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology [Time frame: Baseline, Week 60]
Secondary outcome measures (12)
- 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]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tsinghua Changgung Hospital — Beijing
Identifiers
NCT: NCT06937749 · CIBI362C201