Resmetirom for NASH

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Arkansas Gastroenterology, North Little Rock, AR
NASH+3 More
Resmetirom - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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

2 of 3
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

3 of 3
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: Drug

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.