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Trial · NCT04697810

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNon-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS)36 weeks
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)
PrimaryAdverse events (AEs)36 weeksIncidence of AEs
SecondaryAlanine transaminase (ALT) mean36 weeksMean percent change from Baseline in serum ALT level
SecondarySteady-state blood level of namodenoson36 weeksPlasma trough concentration (ng/mL) of namodenoson taken at pre-dose samples
OtherALT absolute36 weeksAbsolute change from Baseline in serum ALT
OtherALT threshold36 weeksProportion of subjects who achieve ≥17-point reduction from Baseline in serum ALT
OtherWeight36 weeksChange from Baseline in body weight
OtherAdiponectin36 weeksChange from Baseline in serum adiponectin level
OtherReleased N-terminal pro-peptide of type III collagen neoepitope (Pro-C3)36 weeksChange from Baseline in Pro-C3
OtherSerum Enhanced Liver Fibrosis (ELF) Score36 weeksChange from Baseline in ELF Score, which is a continuous scale starting at zero, with higher scores indicating more severe disease
OtherFibroScan controlled attenuation parameter (CAP)36 weeksChange from Baseline in CAP
OtherFibroScan-AST (FAST) Score36 weeksChange from Baseline in FAST Score, which is a decimal score from 0 to 1, with higher scores indicating more severe disease
OtherAspartate transaminase (AST)36 weeksChange from Baseline in serum AST
OtherGamma-glutamyl transferase (GGT)36 weeksChange from Baseline in serum GGT
OtherFibrosis-4 (Fib-4) Index36 weeksChange from Baseline in Fib-4 Index
OtherNASH resolution36 weeksProportion of subjects who achieve histologic NASH resolution as defined by a ballooning score of 0 and an inflammation score of 0-1 without worsening of fibrosis
OtherNASH fibrosis improvement36 weeksProportion of subjects who achieve histologic NASH improvement by at least 1 point without worsening of NASH

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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