Prijedor

Researchers are investigating the effectiveness and safety of namodenoson in adults diagnosed with Non-Alcoholic Steatohepatitis (NASH) with fibrosis stages F1 to F3. This phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to compare oral namodenoson taken every 12 hours with a matching placebo over 36 weeks. The trial includes individuals with biopsy-confirmed NASH and metabolic syndrome characteristics, assessing liver health and related biomarkers. Participants will be randomly assigned in a 2:1 ratio to receive either namodenoson 25 mg or placebo capsules every 12 hours for 36 weeks. Safety evaluations and biomarker measurements occur at baseline and at weeks 6, 12, 24, and 36. At the end of treatment, all participants will undergo a liver biopsy to assess disease activity. After completing treatment, participants will attend a follow-up visit six weeks later. During the study, participants will have regular safety assessments and biomarker tests to monitor liver function and disease progression. The main outcomes measured are the Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS) and recording of any adverse events over the 36-week treatment period. The study requires participants to comply with scheduled visits, treatment plans, laboratory assessments, and to undergo two liver biopsies, including one at screening or within six months prior to baseline.