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NCT06937749·Phase 2·INTERVENTIONAL

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

MazdutideOtherRecruiting

Status

Recruiting

Phase

Phase 2

Enrollment

165

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Placebo

Placebo administered subcutaneously (SC) once a week.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Timeline

From registration to results.

  1. First posted

    Apr 22, 2025

  2. Study start

    Jul 1, 2025

  3. Primary completion

    Apr 30, 2026

  4. Study completion

    Jul 22, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Nov 20, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline, Week 60

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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