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

NCT07145151 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-11-20

No results posted yet for this study

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

DRUG

UBT251

UBT251 administered subcutaneously (SC) once a week.

DRUG

Placebo

Placebo,SC,once a week for 48 weeks

Sponsors & Collaborators

  • The United Bio-Technology (Hengqin) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-06-04
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145151 on ClinicalTrials.gov