Morehead City, NCNCT07848191Now EnrollingIRB Ready

MASH - Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial in Morehead City, NC

Access cutting-edge mash - metabolic dysfunction-associated steatohepatitis treatment through this phase 4 clinical trial at a research site in Morehead City. 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 Morehead City

    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 Morehead City site if eligible
  4. 4Begin participation

About This MASH - Metabolic Dysfunction-Associated Steatohepatitis Study in Morehead City

To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)

Sponsor: Madrigal Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

All Subjects:
Willing to participate in the study and provide written informed consent.
Meets all requirements per REZDIFFRA Prescribing Information, in the opinion of the PI.
Male and female adults ≥18 of age at time of screening.
Evidence of hepatic steatosis consistent with MASH demonstrated by an MRI-PDFF fat fraction \>5% obtained during second screening period.
Evidence of moderate-to-advanced fibrosis (F2-F3) without cirrhosis.
Stable medical conditions and background medications (non-concomitant medications as defined in this protocol) per PI judgement.
Female subjects of reproductive potential are eligible if they 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 1 highly effective birth control method during the study and for at least 30 days after newly introduced medication administration. Highly effective birth control methods include hormonal and non-hormonal intrauterine device, combination estrogen-progesterone hormonal contraception (oral, transdermal, or vaginal), tubal ligation, a vasectomized or sterile male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from Screening throughout the study, and for at least 30 days after newly introduced medication administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the subject's habitual practice. NOTE: Female subjects who are not of child-bearing potential (ie, surgically \[bilateral oophorectomy, hysterectomy\] or naturally sterile \[\>12 consecutive months without menses\]) do not require contraception during the study.
Must be taking a stable dose of ACTOS/pioglitazone for at least 2 months prior to Baseline. (Group A1)
Must be taking a stable dose of FARXIGA/dapagliflozin for at least 2 months prior to Baseline. (Group A2)
Must be taking a stable dose of REZDIFFRA for at least 2 months prior to Baseline. (Groups B1 and B2)
Must not have previously taken RESMETIROM or ACTOS/pioglitazone or FARXIGA/dapagliflozin. (Group C)
For Groups A1, B1, and C1: Meets all requirements per ACTOS/pioglitazone Prescribing Information, in the opinion of the PI.
For Groups B1 and C1: (ie, naïve to ACTOS/pioglitazone): HbA1c at screening ≥7.0% and ≤10.0%.
For Groups A2, B2, and C2: Meets all requirements per FARXIGA/dapagliflozin Prescribing Information, in the opinion of the PI.
For Groups B2 and C2 (ie, naïve to FARXIGA/dapagliflozin): HbA1c at screening ≥7.0% and ≤10.0%.

Exclusion Criteria

All subjects
Off label use of the commercially available study medications.
Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis.
Other chronic liver diseases (eg, viral hepatitis, autoimmune hepatitis, hemochromatosis).
Documented history of decompensated liver disease.
Use of rosuvastatin or simvastatin at a dose greater than 20 mg/day, or pravastatin or atorvastatin at a dose greater than 40 mg/day, at the time of the first dose of resmetirom. Subjects receiving a statin dose above the applicable limit during the screening period may remain eligible if the dose is reduced to the applicable maximum permitted dose before the first dose of resmetirom.
Any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the subject, or interfere with the study outcomes.
Active or suspected bladder cancer.
Diagnosis of heart failure.
eGFR \< 60mL/min/1.73 m2
Developmental/intellectual disability, limited capacity of recognition, any history of clinically important emotional and/or psychiatric illness, inability to follow the study procedures, or any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
Individuals who are currently incarcerated or who are anticipated to be incarcerated during the study period. Groups B and C:
Unable to secure a prescription for a concomitant medication.

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 Morehead City?

Yes, this clinical trial (NCT07848191) has an active research site in Morehead City, 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.

MASH - Metabolic Dysfunction-Associated Steatohepatitis Treatment Options in Morehead City, NC

If you're searching for mash - metabolic dysfunction-associated steatohepatitis treatment options in Morehead City, NC, this clinical trial (NCT07848191) 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 Morehead City research site is actively enrolling participants for this phase 4 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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