Phase IIa Study of AZD2389 Oral Treatment in Adults With Steatotic Liver Disease and Advanced Fibrosis Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Effects

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacodynamic effects of AZD2389 in adults with steatotic liver disease SLD and advanced fibrosis. This Phase IIa study includes about 230 participants screened to enroll approximately 104 adults with SLD and advanced fibrosis. The study compares oral AZD2389 with placebo in a randomized, double-blind, parallel group design. Participants are assigned to one of two groups one receiving oral AZD2389 and the other receiving an oral placebo. The treatment period lasts up to 24 weeks, preceded by a 4-week screening and followed by a 4-week follow-up. Visits occur approximately every 4 weeks, except between Visits 2 and 4, which are every 2 weeks. During the study, participants undergo regular evaluations including blood pressure monitoring, ECGs, urine and blood tests, and safety assessments of vital signs such as heart rate, oxygen levels, body temperature, and respiratory rate. The primary outcome is the change in Enhanced Liver Fibrosis ELF score over 24 weeks. Researchers also track adverse events and other laboratory measurements throughout the treatment and follow-up periods.

Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis