Nonalcoholic SteatohepatitisPhase 2NCT05526144
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
A Phase 2 study testing Synthroid in people with Nonalcoholic Steatohepatitis and Liver Fibrosis, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Liver Fibrosis
- What is being tested?
- Synthroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (pre- and post-menopausal)
- Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
- Alcohol intake < 20 grams per day
- Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment
- Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment
- Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)
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- Scheduled for a medically indicated, diagnostic liver biopsy
- Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [> 12 consecutive months without menses])
- Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration
- Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice
- If a patient is on digitalis and amiodarone, he/she is expected to use/continue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary
Who cannot join
- Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis
- Alcohol consumption of 20 g/d or more
- Patients with cirrhosis, bilirubin of 1.3 mg/dL or more, and INR of 1.3 or more
- Evidence of Portal hypertension
- Pregnancy
- History of malignant hypertension
Show all 14Show fewer
- Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure > 160 mm Hg or a diastolic blood pressure > 100 mm Hg at screening
- New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction < 30%
- Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) > 450 msec for males and > 470 msec for females at the screening electrocardiogram (ECG) assessment
- History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization
- History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker
- Patients with uncorrected adrenal insufficiency
- Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and/or unable to discontinue these medications to allow adequate washout prior to randomization
- Patients who are on Teduglutide or Midodrine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5275
Adam T Whaley-Connell, DO MSPH, 573-814-6552, Adam.Whaley-Connell@va.gov
Jennifer A Atherton, (573) 814-6000 ext. 56550, Jennifer.Atherton@va.gov
About this study
Official title: Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)
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.
Read the detailed description
Nonalcoholic steatohepatitis (NASH) is an aggressive part of the pathological spectrum of nonalcoholic fatty liver disease (NAFLD) that has evolved into a world-wide epidemic and is the most common chronic liver disease in the United States. NASH is strongly linked to obesity, and type 2 diabetes mellitus and may progress to cirrhosis and liver cancer. Disturbingly, prevalence rates of NASH appear to be greater in the Veteran population compared with the general US population. Thus, the burden of NASH is substantial to Veterans. Despite the recognition of NASH as a major public health problem, only lifestyle modifications aimed at increasing physical activity and reducing caloric intake are currently recommended as treatments with limited success. Thus, there is a great need for effective therapy of NASH. The goal of this study is to test whether low dose thyroid hormone administered to Veterans with biopsy-proven NASH, at a titrated dose (25, 50, or 75 mcg daily) that will maintain thyroid function within normal range (TSH at or above 0.47 mIU/L) can result in histological improvement of NASH, measured by significant reduction in nonalcoholic fatty liver disease score (NAS). The hypothesis is that low dose thyroid hormone causes histological improvement in NASH by increasing mitochondrial FAO in the liver mediated by an increase in mitochondrial trifunctional protein (MTP), the key enzyme in FAO cycle. The preliminary clinical studies in human subjects, including Veterans, support reduced FAO in NASH. In addition, preclinical in vivo animal studies and in vitro cell culture studies support that low dose thyroid hormone can effectively increase mitochondrial fatty acid oxidation and rescue NAFLD. In a randomized double-blinded placebo-controlled clinical trial, Veterans with normal thyroid levels and biopsy-proven NASH will be recruited and randomized to receive 52 weeks of either active treatment (low dose levothyroxine at 25, 50, or 75 mcg daily) or placebo control to accomplish the following Specific Aims. 1) To determine the efficacy of low dose thyroid hormone in improving NASH histological features. To accomplish this aim, NAS will be measured in pre- and post-liver biopsy samples. 2) To determine the effect of low dose thyroid hormone on mitochondrial FAO, MTP, and mitochondrial health markers in the liver compared to control. To accomplish this aim, mitochondrial FAO and the expression of genes supporting mitochondrial health will be measured in the pre- and post-liver biopsy samples. The primary clinical outcome is histological improvement in NASH measured by improvement in NAS and the secondary clinical outcome is improvement in fibrosis stage. The mechanistic outcomes include improvements in mitochondrial FAO, MTP, and quality markers. This project will be conducted in two stages. In stage 1 (proof-of-concept, 2 years), 32 Veterans with biopsy-proven NASH will be recruited and randomized to either the active treatment or placebo groups (16/group). At the end of the second year, interim analysis will be performed based on criteria that will include conditional power analysis for early efficacy to determine the probability that the full study will yield a statistically significant finding in the primary outcome (histological improvement in NASH) in the clinically relevant direction. Other milestones include trend in the secondary outcome, adverse events, and feasibility. The outcome from the proof-of-concept stage will guide the Go or No-Go decision to stage 2 for continuation of the study with recruitment of additional Veterans for a full 6-year clinical trial (total recruitment of 128 Veterans with biopsy-proven NASH: 64/active treatment group and 64/placebo control group). This project will exert a sustained and powerful impact in the field by providing new information and strategies for treatment of NASH that will be highly relevant and impactful to the health of the Veteran population.
- Conditions
- Nonalcoholic Steatohepatitis, Liver Fibrosis
- Being tested
- Synthroid, Placebo
- Keywords
- Thyroid hormone, Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), Mitochondrial fatty acid oxidation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynthroidDrug
Also called Levothyroxine, T4
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo group will receive placebo tablets Receives: Drug: Placebo |
| Study group | Active comparator | Study group will receive Synthroid (Levothyroxine) 25, 50, or 75 mcg daily Receives: Drug: Synthroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
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.
Measured: 12 months
Secondary outcomes (4)
Proportion of subjects experiencing improvement in biopsy-determined fibrosis by at least one stage
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.
Measured: 12 months
Improvement in mitochondrial fatty acid oxidation
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.
Measured: 12 months
Improvement in mitochondrial biogenesis
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.
Measured: 12 months
Improvement in mitochondrial mitophagy
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subjects who are eligible for the study will be assigned by block randomization to either the study group arm receiving active treatment of a titrated dose of Synthroid (25, 50, or 75 mcg/day) or placebo (25, 50, or 75 mcg/day).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jamal A Ibdah, MD PhD, Principal investigator, Harry S. Truman Memorial, Columbia, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526144
- Sponsor's protocol ID
- ENDA-010-21F
- Other IDs
- I01CX002436
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained during this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05526144
- Acronym / sponsor ID
- ENDA-010-21F
- Conditions
- Nonalcoholic Steatohepatitis, Liver Fibrosis
- Keywords
- Thyroid hormone, Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), Mitochondrial fatty acid oxidation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nonalcoholic steatohepatitis (NASH) is an aggressive part of the pathological spectrum of nonalcoholic fatty liver disease (NAFLD) that has evolved into a world-wide epidemic and is the most common chronic liver disease in the United States. NASH is strongly linked to obesity, and type 2 diabetes mellitus and may progress to cirrhosis and liver cancer. Disturbingly, prevalence rates of NASH appear to be greater in the Veteran population compared with the general US population. Thus, the burden of NASH is substantial to Veterans. Despite the recognition of NASH as a major public health problem, only lifestyle modifications aimed at increasing physical activity and reducing caloric intake are currently recommended as treatments with limited success. Thus, there is a great need for effective therapy of NASH. The goal of this study is to test whether low dose thyroid hormone administered to Veterans with biopsy-proven NASH, at a titrated dose (25, 50, or 75 mcg daily) that will maintain thyroid function within normal range (TSH at or above 0.47 mIU/L) can result in histological improvement of NASH, measured by significant reduction in nonalcoholic fatty liver disease score (NAS). The hypothesis is that low dose thyroid hormone causes histological improvement in NASH by increasing mitochondrial FAO in the liver mediated by an increase in mitochondrial trifunctional protein (MTP), the key enzyme in FAO cycle. The preliminary clinical studies in human subjects, including Veterans, support reduced FAO in NASH. In addition, preclinical in vivo animal studies and in vitro cell culture studies support that low dose thyroid hormone can effectively increase mitochondrial fatty acid oxidation and rescue NAFLD. In a randomized double-blinded placebo-controlled clinical trial, Veterans with normal thyroid levels and biopsy-proven NASH will be recruited and randomized to receive 52 weeks of either active treatment (low dose levothyroxine at 25, 50, or 75 mcg daily) or placebo control to accomplish the following Specific Aims. 1) To determine the efficacy of low dose thyroid hormone in improving NASH histological features. To accomplish this aim, NAS will be measured in pre- and post-liver biopsy samples. 2) To determine the effect of low dose thyroid hormone on mitochondrial FAO, MTP, and mitochondrial health markers in the liver compared to control. To accomplish this aim, mitochondrial FAO and the expression of genes supporting mitochondrial health will be measured in the pre- and post-liver biopsy samples. The primary clinical outcome is histological improvement in NASH measured by improvement in NAS and the secondary clinical outcome is improvement in fibrosis stage. The mechanistic outcomes include improvements in mitochondrial FAO, MTP, and quality markers. This project will be conducted in two stages. In stage 1 (proof-of-concept, 2 years), 32 Veterans with biopsy-proven NASH will be recruited and randomized to either the active treatment or placebo groups (16/group). At the end of the second year, interim analysis will be performed based on criteria that will include conditional power analysis for early efficacy to determine the probability that the full study will yield a statistically significant finding in the primary outcome (histological improvement in NASH) in the clinically relevant direction. Other milestones include trend in the secondary outcome, adverse events, and feasibility. The outcome from the proof-of-concept stage will guide the Go or No-Go decision to stage 2 for continuation of the study with recruitment of additional Veterans for a full 6-year clinical trial (total recruitment of 128 Veterans with biopsy-proven NASH: 64/active treatment group and 64/placebo control group). This project will exert a sustained and powerful impact in the field by providing new information and strategies for treatment of NASH that will be highly relevant and impactful to the health of the Veteran population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study subjects who are eligible for the study will be assigned by block randomization to either the study group arm receiving active treatment of a titrated dose of Synthroid (25, 50, or 75 mcg/day) or placebo (25, 50, or 75 mcg/day).
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group will receive placebo tablets |
| Study group | Active comparator | Drug: SynthroidStudy group will receive Synthroid (Levothyroxine) 25, 50, or 75 mcg daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women (pre- and post-menopausal)
- Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
- Alcohol intake < 20 grams per day
- Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment
- Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment
Key exclusion criteria (14 listed)
- Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis
- Alcohol consumption of 20 g/d or more
- Patients with cirrhosis, bilirubin of 1.3 mg/dL or more, and INR of 1.3 or more
- Evidence of Portal hypertension
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynthroidAlso: Levothyroxine, T4Synthroid 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. | Drug | Study group |
| PlaceboPlacebo 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. | Drug | Placebo group |
Primary outcome
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
Time frame: 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.
4 secondary outcomes
Proportion of subjects experiencing improvement in biopsy-determined fibrosis by at least one stage
Time frame: 12 months
Improvement in mitochondrial fatty acid oxidation
Time frame: 12 months
Improvement in mitochondrial biogenesis
Time frame: 12 months
Improvement in mitochondrial mitophagy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes. Data obtained during this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamal A Ibdah, MD PhD principal investigator
Harry S. Truman Memorial, Columbia, MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synthroid in people with Nonalcoholic Steatohepatitis and Liver Fibrosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam T Whaley-Connell, DO MSPH ((573) 814-6552, Adam.Whaley-Connell@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.