Washington Dc, DCNCT07335601Now EnrollingIRB Ready

MASH - Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial in Washington Dc, DC

Access cutting-edge mash - metabolic dysfunction-associated steatohepatitis treatment through this clinical trial at a research site in Washington Dc. Study-provided care at no cost to qualified participants.

Sponsored by Madrigal Pharmaceuticals, Inc.

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mash - metabolic dysfunction-associated steatohepatitis treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Washington Dc

    Convenient for DC 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 Washington Dc site if eligible
  4. 4Begin participation

About This MASH - Metabolic Dysfunction-Associated Steatohepatitis Study in Washington Dc

A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.

Sponsor: Madrigal Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

At least 12 months post-liver transplant at screening and meeting one of the following:
Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF
Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF
Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.
MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or graft rejection.
Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening.
Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.
Stable immunosuppressive regimen for at least 3 months prior to screening.
Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible.

Exclusion Criteria

Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
Evidence of active liver disease other than MASH.
History of liver transplantation for an inborn error of metabolism.
Evidence of hepatic impairment or decompensation at screening.
Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.
Chronic rejection or chronic plasma-cell hepatitis.
Significant post-transplant vascular or biliary complications.
Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.
Uncontrolled hypertension at screening or randomization.
Current hepatocellular carcinoma.
Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.
Any serious medical condition with a life expectancy of less than 5 years.
Current substance abuse or drug addiction.
Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment.
Known hypersensitivity to study drug or any of its excipients.
Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization.
Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization.
Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.

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 Washington Dc?

Yes, this clinical trial (NCT07335601) has an active research site in Washington Dc, DC 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.

MASH - Metabolic Dysfunction-Associated Steatohepatitis Treatment Options in Washington Dc, DC

If you're searching for mash - metabolic dysfunction-associated steatohepatitis treatment options in Washington Dc, DC, this clinical trial (NCT07335601) 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 Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mash - metabolic dysfunction-associated 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 mash - metabolic dysfunction-associated steatohepatitis clinical trials near you to find additional studies recruiting in your area.

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