Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

Part of paid clinical trials in Columbia, Missouri.

Sponsor
VA Office of Research and Development
Study ID
NCT05526144
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Synthroid — DRUG
    Synthroid tablets 25 mcg. Subjects in the study group will receive Synthroid at a titrated dose of 25 mcg (one tablet), 50 mcg (two tablets), or maximum of 75 mcg (3 tablets) daily for one year duration that will maintain TSH at normal level.
  • Placebo — DRUG
    Placebo tablets 25 mcg daily. Subjects in the placebo group will receive placebo tablets at a dose of 25 mcg (one tablet), 50 mcg (two tablets), or maximum of 75 mcg (3 tablets) daily for a one year duration.

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo group
    Placebo group will receive placebo tablets
  • Active Comparator: Study group
    Study group will receive Synthroid (Levothyroxine) 25, 50, or 75 mcg daily

Primary Outcome Measure

Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harry S. Truman Memorial, Columbia, MOColumbiaMissouri65201-5275
Adam T Whaley-Connell, DO MSPH
[email protected]
573-814-6552
Jennifer A Atherton
[email protected]
(573) 814-6000
Jamal A Ibdah, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Harry S. Truman Memorial, Columbia, MO· Columbia, MO

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