A Study of IBI362 in Participants With Metabolic 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
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
Treatments tested in this trial
- Placebo
- IBI362
Treatment groups
165 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov