Madrigal Pharmaceuticals, Inc.
To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)
This Phase 4 study will evaluate the safety and tolerability of REZDIFFRA® (resmetirom) when used in combination with concomitant therapies commonly used to treat diabetes in adults with metabolic dysfunction-associated steatohepatitis (MASH) and noncirrhotic, moderate-to-advanced (F2-F3) fibrosis. The concomitant therapies evaluated in this study will include ACTOS®/pioglitazone and FARXIGA®/dapagliflozin. All study medications will be administered according to their approved labeling. Participants will be assigned to one of six cohorts based on their existing therapy and the concomitant med…
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 judg…
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 - weight-based dosing: * \<100 kg: 80 mg orally once daily. * ≥100 kg: 100 mg orally once daily
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
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)