A Phase 2a double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of GL0034 in adults with at-risk metabolic dysfunction-associated steatohepatitis (MASH)

This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of participants with at-risk metabolic dysfunction-associated steatohepatitis (MASH). Approximately 60 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 2:1. GL0034/Placebo is administered weekly as a subcutaneous injection given by a registered nurse for a period of 24 weeks, The dose will be increased gradually for a period of 4 weeks (called the Dose Titration Period). Participants will then receive a final fixed dose (called the Final Dose Period). Vital signs including temperature, blood pressure and weight will be regularly reviewed in addition to the collection of blood tests every 2-4 weeks to assess overall health and any study drug effects. Blood samples will be collected prior to dosing at week 1 and weekly from weeks 13-27. Blood samples will also be collected 24hrs after dosing at week 13 and 17 and at the following timepoints after the final dose of the study at week 24: Post-dose 1 day, 2 days, 4 days, 7 days, 14 days, 21 days and 28 days The purpose of these blood samples is to measure the levels of GL0034 in the blood.