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

ConditionMetabolic Dysfunction-associated Steatohepatitis (MASH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Placebo administered subcutaneously (SC) once a week.

  • IBI362

    Drug

    IBI362 administered subcutaneously (SC) once a week.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: IBI362 Low DoseExperimental treatment 1 intervention
Group B: IBI362 High DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Week 60

Secondary outcomes

1

Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology

Time frame
Baseline, Week 60
2

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

Time frame
Baseline, Week 60
3

Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology

Time frame
Baseline, Week 60
4

Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology

Time frame
Baseline, Week 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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