Phase 4: testing Rezdiffra for MASH - Metabolic Dysfunction-Associated Steatohepatitis
To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)
Official registry: https://clinicaltrials.gov/study/NCT07848191 · Madrigal Pharmaceuticals, Inc. · enrollment listed as 150
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Rezdiffra, Resmetirom, or ACTOS/pioglitazone. The registry lists allocation as randomized. To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)
They plan to enroll about 150 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 4, Open-label, Multi-group Study of Rezdiffra® in Combination With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and Moderate to Advanced (F2-F3) Fibrosis, Administered According to Their Approved Labeling
Interventions: Rezdiffra, Resmetirom, ACTOS/pioglitazone, FARXIGA/dapagliflozin
Primary outcome (registry wording): Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- 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)
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Tom Hare
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
16 listed- 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)
FAQ about this NCT record
Is NCT07848191 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07848191?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07848191?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary