Actively Recruiting
A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by The United Bio-Technology (Hengqin) Co., Ltd. · Updated on 2025-11-20
156
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive at screening
- Confirmed diagnosis of MASH by liver histopathology with NAS score of 4 or higher including lobular inflammation and ballooning degeneration
- Liver fibrosis stage F2 or F3 confirmed by biopsy within 6 months before screening
- MRI-PDFF value of 8% or higher at screening
- Body weight fluctuation less than 5% during the 6 weeks before randomization
- At least one cardiometabolic risk factor such as BMI ≥24 kg/m² or high blood pressure or abnormal lipid or glucose levels
- For subjects with type 2 diabetes, HbA1c ≤9.0% and stable glycemic control for at least 3 months
- Use of contraception and no plans for pregnancy or sperm/oocyte donation during and 6 months after the trial
- Ability to provide informed consent and comply with study requirements including liver biopsies
You will not qualify if you...
- Known allergy to study drug or GLP-1 receptor agonists or significant history of severe allergies
- Use of GLP-1 receptor agonists or other specified liver-related drugs within 3 months before screening
- Chronic liver diseases other than MASH
- Type 1 diabetes or other specific diabetes types except resolved gestational diabetes
- Recent pancreatitis, pancreatic surgery, or symptomatic gallbladder disease within 1 year
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Severe psychiatric disorders
- Active cardiovascular or cerebrovascular disease within 6 months
- Retinal diseases needing urgent treatment
- History of severe hypoglycemia or frequent episodes in last 2 months
- Gastrointestinal motility disorders or conditions increasing drug risks
- Major surgery, severe trauma, or infection within 1 month
- History of malignancy except specified treated cancers
- Other diseases affecting safety or compliance as judged by investigator
- Abnormal lab results including severe liver or kidney impairment, abnormal blood counts, coagulation, or cardiac abnormalities
- Contraindications to liver biopsy
- Positive for hepatitis B, hepatitis C with active infection, HIV, or syphilis (except cured)
- Significant recent blood loss or transfusions
- MRI contraindications such as implants or severe claustrophobia
- Participation in another clinical trial recently
- Excessive alcohol consumption in past year
- Pregnant or lactating females
- Intolerance to venipuncture or needle phobia
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua ChangGung Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
H
Haiyan Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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