Durham, NCNCT07143968Now EnrollingIRB Ready

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Clinical Trial in Durham, NC

Access cutting-edge masld - metabolic dysfunction-associated steatotic liver disease treatment through this clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Naga P. Chalasani

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Expert Care in Durham

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related masld - metabolic dysfunction-associated steatotic liver disease treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC 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 Durham site if eligible
  4. 4Begin participation

About This MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Study in Durham

The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD. Researchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver. Participants will: * Complete 3 screening visits to determine eligibility. * Take resmetirom or placebo every day for 24 weeks if eligible. * Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment. * Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments. * Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.

Sponsor: Naga P. Chalasani

Who Can Participate

Inclusion Criteria

Adults (≥18 years of age) with documented HIV.
Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.
Hepatic fat fraction ≥8% by MRI-PDFF.
Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB/m
HIV-1 RNA \<200 copies/mL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).
Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
Willingness to participate in the study.

Exclusion Criteria

History of significant alcohol consumption (defined as \>2 drinks/day on average for men, \>1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening
History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.
History of liver transplant.
Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
Inability to undergo MRI testing
Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \>9.5% at screening.
Any of the following laboratory values at screening:
ALT or AST \>250 U/L.
Total bilirubin (TBL) \>1.5 mg/dL and direct bilirubin \> 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).
Platelet count \<150,000/mm3.
Estimated glomerular filtration rate (e-GFR) \<60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation
International normalized ratio (INR) \>1.3.
Albumin \< 3.6 g/dL
Liver stiffness measurement (LSM) by VCTE \> 20 kPa
Further exclusion criteria apply

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 Durham?

Yes, this clinical trial (NCT07143968) has an active research site in Durham, NC 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.

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Treatment Options in Durham, NC

If you're searching for masld - metabolic dysfunction-associated steatotic liver disease treatment options in Durham, NC, this clinical trial (NCT07143968) 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 Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced masld - metabolic dysfunction-associated steatotic liver disease 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 masld - metabolic dysfunction-associated steatotic liver disease clinical trials near you to find additional studies recruiting in your area.

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