Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
ConditionNASH - Nonalcoholic Steatohepatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCan-Fite BioPharma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
AST at Screening of ≥20 IU/L.
FibroScan LSM ≥8.5 kPa
Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.
Disqualifiers
Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.
Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
Weight loss of >5% within 3 months prior to Baseline.
Trial design
Design model
Parallel
Treatments tested in this trial
Namodenoson
Drug25 mg q12hours x 36 weeks
Placebo
DrugMatching capsules q12hours x 36 weeks
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: NamodenosonExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
Adverse events (AEs)
Incidence of AEs
Time frame
36 weeksSecondary outcomes
1
Alanine transaminase (ALT) mean
Mean percent change from Baseline in serum ALT level
Time frame
36 weeks2
Steady-state blood level of namodenoson
Plasma trough concentration (ng/mL) of namodenoson taken at pre-dose samples
Time frame
36 weeksOther outcomes
1
ALT absolute
Absolute change from Baseline in serum ALT
Time frame
36 weeks2
ALT threshold
Proportion of subjects who achieve ≥17-point reduction from Baseline in serum ALT
Time frame
36 weeks3
Weight
Change from Baseline in body weight
Time frame
36 weeks4
Adiponectin
Change from Baseline in serum adiponectin level
Time frame
36 weeksSponsors and contacts
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Source ClinicalTrials.gov