Columbia, MONCT05526144Now EnrollingIRB Ready

Nonalcoholic Steatohepatitis Clinical Trial in Columbia, MO

Access cutting-edge nonalcoholic steatohepatitis treatment through this clinical trial at a research site in Columbia. Study-provided care at no cost to qualified participants.

Sponsored by VA Office of Research and Development

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Expert Care in Columbia

Access nonalcoholic steatohepatitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related nonalcoholic steatohepatitis treatment provided free

Apply for This Columbia Location

Check if you qualify for this nonalcoholic steatohepatitis clinical trial in Columbia, MO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Columbia

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Columbia site if eligible
  4. 4Begin participation

About This Nonalcoholic Steatohepatitis Study in Columbia

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.

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

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)
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

Exclusion Criteria

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
History of malignant hypertension
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbia?

Yes, this clinical trial (NCT05526144) has an active research site in Columbia, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Nonalcoholic Steatohepatitis Treatment Options in Columbia, MO

If you're searching for nonalcoholic steatohepatitis treatment options in Columbia, MO, this clinical trial (NCT05526144) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced nonalcoholic steatohepatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all nonalcoholic steatohepatitis clinical trials near you to find additional studies recruiting in your area.

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