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

ConditionMetabolic Dysfunction-associated Steatohepatitis (MASH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

NAS (Appendix 1) ≥ 4 （with at least 1 point each for lobular inflammation and ballooning degeneration）;

CRN fibrosis stage (see Appendix 2) of F2 or F3 (a liver biopsy obtained ≤ 6 months before screening is acceptable if it meets the above criteria).

Body mass index (BMI) ≥ 24.0 kg/m², or waist circumference ≥90 cm for males or ≥85 cm for females;

Blood pressure ≥ 130/85 mmHg, or on antihypertensive therapy;

Disqualifiers

Known hypersensitivity to the investigational product or any of its excipients, or allergy to other GLP-1 receptor agonists, or clinically significant history of multiple/severe drug allergies, or current allergic diseases or hypersensitivity diathesis;

Chronic liver disease other than MASH (e.g., autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, chronic liver disease-related ascites, esophageal varices, hepatic encephalopathy, etc.).

Diagnosis of type 1 diabetes or other specific types of diabetes, except resolved gestational diabetes;

Acute pancreatitis or chronic pancreatitis within 1 year prior to screening, history of pancreatic surgery; or symptomatic gallbladder disease within 1 year prior to screening (e.g., choledocholithiasis, multiple gallstones, etc., except those who underwent cholecystectomy or stone removal);

Trial design

Design model

Parallel

Treatments tested in this trial

  • UBT251

    Drug

    UBT251 administered subcutaneously (SC) once a week.

  • Placebo

    Drug

    Placebo,SC,once a week for 48 weeks

Treatment groups

156 Participants
are divided into 4 treatment groups
Group A: UBT251 Low DoseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: UBT251 Middle DoseExperimental treatment 1 intervention
Group D: UBT251 High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology

Time frame
Baseline, Week 48

Secondary outcomes

1

Proportion of Participants with MASH improvement with a ≥1-stage histological improvement in liver fibrosis.

Time frame
Baseline, Week 48
2

Proportion of Participants with MASH resolution with a ≥1-stage histological improvement in liver fibrosis.

Time frame
Baseline, Week 48
3

Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology

Time frame
Baseline, Week 48
4

Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]

Time frame
Baseline, Week 12, Week 24, Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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