Resmetirom for NASH
Phase-Based Progress Estimates
Effectiveness
Safety
Arkansas Gastroenterology, North Little Rock, AR
NASH+3 More
Resmetirom - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.
Eligible Conditions
- NASH
- Cirrhosis of the Liver
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Baseline up to Month 36
Month 36
Incidence Of adjudicated Composite Clinical Outcome event
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Resmetirom
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
700 Total Participants · 2 Treatment Groups
Primary Treatment: Resmetirom · Has Placebo Group · Phase 3
PlaceboPlaceboComparator Group · 2 Interventions: Resmetirom, Placebo · Intervention Types: Drug, Drug
Resmetirom
Drug
ActiveComparator Group · 1 Intervention: Resmetirom · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to month 36
Closest Location: Arkansas Gastroenterology · North Little Rock, AR
2005First Recorded Clinical Trial
1 TrialsResearching NASH
36 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a definite or probable diagnosis of non-alcoholic steatohepatitis (NASH) as the cause of cirrhosis.
You have at least 3 metabolic risk factors.
You have a MRE score of 4.2 or higher.
You have enhanced liver function (ELF) ≥9.8.
You have NASH cirrhosis on most recent biopsy.
You have histological evidence of nonalcoholic steatohepatitis (NASH) with significant fibrosis, now with progression to cirrhosis based on clinical diagnosis, which is estimated to be approximately 20% of the study population.
You have histological evidence of NASH with steatosis, now with progression to cirrhosis based on clinical diagnosis, which is estimated to be approximately 10% of the study population.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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