Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of UBT251 Injection in Adults 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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating UBT251, a drug given by weekly injection, in adults with metabolic dysfunction-associated steatohepatitis (MASH), a liver condition linked to metabolic problems. This randomized, double-blind, placebo-controlled Phase 2 study aims to assess the safety and effectiveness of three different doses of UBT251 compared to placebo. The study includes adults aged 18 to 75 years and is sponsored by The United Bio-Technology (Hengqin) Co., Ltd. Participants are randomly assigned to one of four groups: low, middle, or high doses of UBT251 or placebo. Doses are administered subcutaneously once a week for 48 weeks, with an initial 4-week dose escalation phase for some groups. The trial consists of a 6-week screening period, a 48-week treatment period, and a 4-week follow-up period after treatment ends. During the study, participants will undergo liver biopsies, MRI scans, blood tests, and other assessments to monitor liver health, metabolic factors, and safety. Researchers will measure the percentage of participants whose MASH resolves without worsening liver fibrosis, along with changes in liver fat, body weight, blood markers, and insulin resistance. Participants' adherence and safety will be closely monitored throughout the trial lasting over a year from screening to follow-up.
CONDITIONS
Brief 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
- Diagnosis of MASH confirmed by liver biopsy with NAS score of 4 or higher, including inflammation and ballooning degeneration
- Liver fibrosis stage F2 or F3 based on biopsy within 6 months before screening
- MRI-PDFF liver fat measurement of 8% or higher at screening
- Body weight fluctuation less than 5% in the 6 weeks before randomization
- Presence of at least one cardiometabolic risk factor such as BMI �3 24 kg/m2 or elevated waist circumference, high blood pressure or on antihypertensive therapy, specific lipid levels or on lipid-lowering therapy, elevated fasting glucose or HbA1c, or insulin resistance
- For type 2 diabetes patients: HbA1c �3 9.0% and stable glucose control regimen for at least 3 months
- Use of contraception and no pregnancy plans through 6 months post-trial
- Ability and willingness to provide informed consent and comply with study procedures including liver biopsies
You will not qualify if you...
- Known allergy to UBT251, GLP-1 receptor agonists, or related drugs
- Recent use of GLP-1 receptor agonists or related medications within 3 months before screening
- Use or planned use of certain drugs affecting liver or metabolic function within 3 months before screening
- Unstable doses of statins, fibrates, or PCSK9 inhibitors within 1 month before screening
- Other liver diseases besides MASH
- Type 1 diabetes or other specific diabetes types except resolved gestational diabetes
- Recent pancreatitis or symptomatic gallbladder disease within 1 year
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Severe psychiatric disorders
- Recent serious cardiovascular or cerebrovascular events within 6 months
- Eye diseases requiring urgent treatment
- History of severe hypoglycemia or frequent hypoglycemia episodes
- Gastrointestinal motility disorders or uncontrolled gastrointestinal diseases
- Major surgery, severe trauma, or severe infection within 1 month
- History of certain cancers except adequately treated localized types
- Other significant diseases affecting safety or compliance
- Laboratory abnormalities indicating liver or kidney impairment or abnormal blood tests
- Contraindications to liver biopsy
- Positive tests for hepatitis B, hepatitis C, HIV, or active syphilis
- Recent blood loss or transfusions
- MRI contraindications
- Participation in other clinical trials recently
- Excessive alcohol use within 12 months
- Pregnancy or breastfeeding
- Needle phobia or intolerance to venipuncture
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive weekly subcutaneous injections of UBT251 or placebo for up to 48 weeks, with dose levels changing during the treatment period depending on the assigned group.
Weekly visits for up to 48 weeks
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua ChangGung Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
H
Haiyan Zhang
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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