NCT07145151

A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

A Phase 2, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of UBT251 Injection in Adult Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of UBT251 in MASH subjects. Subjects will be randomly assigned to UBT251 2mg-dose, 4mg-dose，6mg-dose and placebo groups. The entire trial cycle includes a 6-week screening period, a 48-week double-blind treatment period, and a 4-week follow-up period.

Conditions

• Metabolic Dysfunction-associated Steatohepatitis (MASH)

Interventions

Type	Name	Description
DRUG	UBT251	UBT251 administered subcutaneously (SC) once a week.
DRUG	Placebo	Placebo,SC,once a week for 48 weeks

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-06-04
• Completion: 2027-08-31
• First posted: 2025-08-28
• Last updated: 2025-11-20

Locations

1 site across 1 country: China