Trial · NCT05526144
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
NCT05526144, Phase 2, Recruiting, VA Office of Research and Development
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans. Trials, record NCT05526144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05526144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
- NCT number
- NCT05526144
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 128 participants, estimated
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Nonalcoholic Steatohepatitis, Liver Fibrosis
- Interventions
- Synthroid, Placebo
- First posted
- 2022-09-02
- Last updated
- 2026-02-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points | 12 months | To examine the efficacy of daily low dose Synthroid, using a dose-titration strategy based on serum thyroid stimulating hormone (TSH), on the histological progression of nonalcoholic steatohepatitis (NASH) in Veterans with normal serum TSH levels and biopsy-proven NASH, and to compare the treated patients with Veterans on placebo. Liver biopsies will be obtained at baseline (Week 0) and at end of treatment (Week 52). Nonalcoholic fatty liver disease activity score (NAS) will be assessed in baseline and post treatment liver biopsies and improvement in NAS will be compared between study group on active treatment and placebo group. |
| Secondary | Proportion of subjects experiencing improvement in biopsy-determined fibrosis by at least one stage | 12 months | The stage of liver fibrosis will be assessed in the study subjects at baseline and post intervention. Improvement in the stage of fibrosis will be compared between the placebo and study groups. |
| Secondary | Improvement in mitochondrial fatty acid oxidation | 12 months | Effect of Synthroid on mitochondrial fatty acid oxidation will be assessed by measurement of complete mitochondrial fatty acid oxidation in liver tissue obtained at baseline and post intervention (52 weeks) in study and placebo groups. |
| Secondary | Improvement in mitochondrial biogenesis | 12 months | Effect of Synthroid on mitochondrial biogenesis will be assessed by measurement of PCG-1alpha (peroxisome-proliferator-activated receptor gamma coactivator 1 alpha) gene expression in the liver tissue at baseline and post intervention at 52 weeks in the study and placebo groups. |
| Secondary | Improvement in mitochondrial mitophagy | 12 months | Effect of Synthroid on mitochondrial mitophagy will be assessed by measurement of BNIP3 (BCL2 interacting protein 3) gene expression in the liver tissue at baseline and post intervention at 52 weeks in the study and placebo groups. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| I01CX002436 | Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH) | IBDAH, JAMAL A | HARRY S. TRUMAN MEMORIAL VA HOSPITAL | Veterans Affairs | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05526144
GET https://conductscience.org/api/trials/v1/NCT05526144/registered