University Park, FLNCT07830758Now EnrollingIRB Ready

MASH - Metabolic Dysfunction-Associated Steatohepatitis Clinical Trial in University Park, FL

Access cutting-edge mash - metabolic dysfunction-associated steatohepatitis treatment through this phase 1 clinical trial at a research site in University Park. 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 University Park

    Convenient for FL 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 University Park site if eligible
  4. 4Begin participation

About This MASH - Metabolic Dysfunction-Associated Steatohepatitis Study in University Park

This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). Participants are randomized 2:1 to resmetirom or placebo for 24 weeks.

Sponsor: Madrigal Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

Must be willing to participate in the study and provide written informed consent.
Male and female adults ≥18 years of age.
Suspected or confirmed diagnosis of fibrotic MASH suggested by the historical data and meets at least 1 criteria for fibrotic MASH
Confirmed diagnosis of HFpEF
Structural and/or functional heart disease based on echocardiographic evaluation.
eGFR ≥45 mL/min/1.73 m2
Female patients 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 study drug 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 study drug administration.

Exclusion Criteria

Patients with cirrhosis and other etiologies of chronic liver disease
PEth value of ≥20 ng/mL measured at Screening OR history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
Thyroid disease:
Active hyperthyroidism
Untreated clinical hypothyroidism defined by TSH \>7 IU/L with symptoms of hypothyroidism or \>10 IU/L without symptoms
History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
Weight gain or loss \>5% total body weight within 12 weeks prior to randomization
HbA1c \>9.0%
Diagnosis of HCC
MELD score ≥12, as determined at Screening, due to liver disease
Hepatic decompensation or impairment.
Has an active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease, or autoimmune hepatitis, requiring systemic treatment within the past 12 weeks or a documented history of clinically severe autoimmune disease, including autoimmune liver disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Serum ALT \>250 U/L
Platelet count \<140,000/mm3. Patients with platelets \<140,000 and ≥120,000/mm3 are eligible if FIB-4 score \<3.5.
History of biliary diversion
Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \>170 mmHg or a diastolic blood pressure \>100 mmHg at Screening
Confirmed QTcF \>450 msec for males and \>470 msec for females at the Screening ECG assessment;
Presence of sustained atrial fibrillation at time of Screening or history of paroxysmal atrial fibrillation episodes for the last 3 months prior to Screening

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 University Park?

Yes, this clinical trial (NCT07830758) has an active research site in University Park, FL 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 University Park, FL

If you're searching for mash - metabolic dysfunction-associated steatohepatitis treatment options in University Park, FL, this clinical trial (NCT07830758) 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 University Park research site is actively enrolling participants for this phase 1 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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