A Study of UBT251 in Participants With Metabolic 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
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
Treatments tested in this trial
- UBT251
- Placebo
Treatment groups
156 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov