Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with a diagnosis of NASH and F1-3 fibrosis. Subjects will undergo Screening procedures during the 6 weeks preceding Baseline. Subjects (n = \~114) will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo post-treatment liver biopsy, which will be interpreted by a blinded expert hepatopathologist. Subjects will return for a follow-up visit 6 weeks after completion of the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
25 mg q12hours x 36 weeks
Matching capsules q12hours x 36 weeks
Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS)
Proportion of subjects who achieve a ≥2-point improvement in the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASH CRN)
Time frame: 36 weeks
Adverse events (AEs)
Incidence of AEs
Time frame: 36 weeks
Alanine transaminase (ALT) mean
Mean percent change from Baseline in serum ALT level
Time frame: 36 weeks
Steady-state blood level of namodenoson
Plasma trough concentration (ng/mL) of namodenoson taken at pre-dose samples
Time frame: 36 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
941 Univ of Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
NOT_YET_RECRUITING942 Health Inst General Hospital, Dept of Internal Medicine
Prijedor, Bosnia and Herzegovina
NOT_YET_RECRUITING934 Second Dept of Internal Disease, MHAT Sveta Karidad EAD
Plovdiv, Bulgaria
NOT_YET_RECRUITING932 Office of Gastroenterology, Medical Center Sansi EOOD
Rousse, Bulgaria
NOT_YET_RECRUITING931 Clinic of Gastroenterology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia
Sofia, Bulgaria
NOT_YET_RECRUITING933 Clinic of Gastroenterology, University Multiprofile Hosptial for Active Treatment
Sofia, Bulgaria
NOT_YET_RECRUITING935 Dept of Gastroent., Univ Multiprofile Hospital for Active Treatment and Emergency Medicine
Sofia, Bulgaria
NOT_YET_RECRUITING936 Office of Gastroenterology, Diagnostic - Consultative Center XX
Sofia, Bulgaria
NOT_YET_RECRUITING937 Office of Gastroenterology, Diagnostic - Consultative Center Alexandrovska
Sofia, Bulgaria
NOT_YET_RECRUITING938 Clinic of Gastroenterology, University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski"
Sofia, Bulgaria
NOT_YET_RECRUITING...and 14 more locations