Ireland
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Recruiting Phase 4

Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis

NCT07848191 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2026-10-07
Last updated
2026-10-16

Condition(s) studied

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Investigational drug(s) / intervention(s)

Rezdiffra →Resmetirom →ACTOS/pioglitazoneFARXIGA/dapagliflozin

Rezdiffra: All study medications will be administered according to their labels: • REZDIFFRA- Label weight-based dosing: * \<100 kg: 80 mg orally once daily. * ≥100 kg: 100 mg orally once daily

Resmetirom: Resmetirom - weight-based dosing: * \<100 kg: 80 mg orally once daily. * ≥100 kg: 100 mg orally once daily

ACTOS/pioglitazone: Label dosing recommendations indicated for patients without congestive heart failure (15 or 30 mg orally once daily; if tolerated, increase by 15 mg increments up to a maximum of 45 mg orally once daily for additional glycemic control

FARXIGA/dapagliflozin: Label dosing recommendations indicated for glycemic control in type 2 diabetes (5 mg orally once daily; if tolerated, increase to 10 mg orally once daily for additional glycemic control)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria All Subjects: 1. Willing to participate in the study and provide written informed consent. 2. Meets all requirements per REZDIFFRA Prescribing Information, in the opinion of the PI. 3. Male and female adults ≥18 of age at time of screening. 4. Evidence of hepatic steatosis consistent with MASH demonstrated by an MRI-PDFF fat fraction \>5% obtained during second screening period. 5. Evidence of moderate-to-advanced fibrosis (F2-F3) without cirrhosis. 6. Stable medical conditions and background medications (non-concomitant medications as defined in this protocol) per PI judgement. 7. 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. 8. Must be taking a stable dose of ACTOS/pioglitazone for at least 2 months prior to Baseline. (Group A1) 9. Must be taking a stable dose of FARXIGA/dapagliflozin for at least 2 months prior to Baseline. (Group A2) 10. Must be taking a stable dose of REZDIFFRA for at least 2 months prior to Baseline. (Groups B1 and B2) 11. Must not have previously taken RESMETIROM or ACTOS/pioglitazone or FARXIGA/dapagliflozin. (Group C) 12. For Groups A1, B1, and C1: Meets all requirements per ACTOS/pioglitazone Prescribing Information, in the opinion of the PI. 13. For Groups B1 and C1: (ie, naïve to ACTOS/pioglitazone): HbA1c at screening ≥7.0% and ≤10.0%. 14. For Groups A2, B2, and C2: Meets all requirements per FARXIGA/dapagliflozin Prescribing Information, in the opinion of the PI. 15. For Groups B2 and C2 (ie, naïve to FARXIGA/dapagliflozin): HbA1c at screening ≥7.0% and ≤10.0%. Exclusion Criteria All subjects 1. Off label use of the commercially available study medications. 2. Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis. 3. Other chronic liver diseases (eg, viral hepatitis, autoimmune hepatitis, hemochromatosis). 4. Documented history of decompensated liver disease. 5. 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. 6. 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. 7. Active or suspected bladder cancer. 8. Diagnosis of heart failure. 9. eGFR \< 60mL/min/1.73 m2 10. 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. 11. Individuals who are currently incarcerated or who are anticipated to be incarcerated during the study period. Groups B and C: 12. Unable to secure a prescription for a concomitant medication.

Primary outcome measure(s)

  • Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — From First Dose of newly introduced medication up to 28 weeks
    The total number of TEAEs and the number and percentage of participants with at least 1 TEAE will be summarized by study group. TEAEs will also be summarized by System Organ Class and Preferred Term.
  • Number and Percentage of Participants With TEAEs by Maximum Severity — From First Dose of newly introduced medication up to 28 weeks
    The number and percentage of participants with TEAEs will be summarized by maximum severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
  • Number and Percentage of Participants With TEAEs by Relationship to Study Medication — From First Dose of newly introduced medication up to 28 weeks
    The number and percentage of participants with TEAEs assessed as Related or Not Related to each applicable study medication (REZDIFFRA/resmetirom, ACTOS/pioglitazone, or FARXIGA/dapagliflozin) will be summarized by study group.

Trial sites (16)

FacilityCityRegionStatus
Arizona Liver Health - Chandler Chandler Arizona Not Yet Recruiting
Arkansas Gastroenterology North Little Rock Arkansas Not Yet Recruiting
Southern California Research Center Coronado California Not Yet Recruiting
Inland Empire Liver Foundation Rialto California Not Yet Recruiting
Florida Research Institute Lakewood Rch Florida Not Yet Recruiting
Gastro Health PLLC Galloway Miami Florida Recruiting
Med Research of Florida, LLC Miami Florida Not Yet Recruiting
Elevate Clinical Research Lake Charles Louisiana Recruiting
Centricity Research - Morehead City - Multispecialty - PPDS Morehead City North Carolina Not Yet Recruiting
Gastro Health Research Cincinnati Ohio Recruiting
University Diabetes and Endocrine Consultants Chattanooga Tennessee Not Yet Recruiting
Texas Clinical Research Institute Arlington Texas Not Yet Recruiting
South Texas Endocrinology & Metabolism Center Corpus Christi Texas Not Yet Recruiting
The Liver Institute at Methodist Dallas Medical Center Dallas Texas Not Yet Recruiting
Elevate Clinical Research - McAllen - PPDS McAllen Texas Not Yet Recruiting
Diabetes and Glandular Disease Clinic, PA San Antonio Texas Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07848191 on ClinicalTrials.gov ↗ ← All trials in the USA