Study group for Fibrosis, Liver

Phase-Based Progress Estimates

Effectiveness

Safety

Harry S. Truman Memorial, Columbia, MO, Columbia, MO

Fibrosis, Liver+4 More

Synthroid - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study 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.

Eligible Conditions

Non Alcoholic Steatohepatitis (NASH)
Fibrosis, Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Fibrosis, Liver

FemBloc

Cotadutide 300μg

CSG452

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 months

12 months

Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points

Improvement in mitochondrial biogenesis

Improvement in mitochondrial fatty acid oxidation

Improvement in mitochondrial mitophagy

Proportion of subjects experiencing improvement in biopsy-determined fibrosis by at least one stage

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Fibrosis, Liver

FemBloc

Cotadutide 300μg

CSG452

Trial Design

2 Treatment Groups

Study group

1 of 2

Placebo group

1 of 2

Active Control

Non-Treatment Group

128 Total Participants · 2 Treatment Groups

Primary Treatment: Study group · Has Placebo Group · Phase 2

Placebo group

Drug

PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Study group

Drug

ActiveComparator Group · 1 Intervention: Synthroid · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 12 months

Closest Location: Harry S. Truman Memorial, Columbia, MO · Columbia, MO

2011First Recorded Clinical Trial

1 TrialsResearching Fibrosis, Liver

3 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You are overweight or obese.\n

You have type 2 diabetes and are on stable antidiabetic medication for at least 3 months before enrollment.

Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice.

About The Reviewer

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.

References