drugset / Trial / NCT05526144

Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

NCT05526144

Phase 2 Recruiting 128 enrolled VA Office of Research and Development
RandomizedParallel-groupTriple-blindTreatment

Summary

Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.

Timeline

Start
2023-04-01
Primary completion
2029-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levothyroxine Other / unclassified 25 ug
Comparator Levothyroxine Other / unclassified 50 ug
Comparator Levothyroxine Other / unclassified 75 ug