Phase 2 Study of Weekly UBT251 Injection for Adults With Metabolic Dysfunction-Associated Steatohepatitis MASH

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.

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