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

Korábbi kezelés

• Off label use of the commercially available study medications.
• 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.
• Unable to secure a prescription for a concomitant medication.

Más betegség

• 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.
• 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.

Laborértékek

• eGFR < 60mL/min/1.73 m2

Egyéb

• Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis.
• Individuals who are currently incarcerated or who are anticipated to be incarcerated during the study period.
  • Groups B and C:

• 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%.