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

ConditionMASH - Metabolic Dysfunction-Associated Steatohepatitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMadrigal Pharmaceuticals, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rezdiffra

    Drug

    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

    Drug

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

  • ACTOS/pioglitazone

    Drug

    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

    Drug

    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)

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Actos (pioglitazone) [Ongoing] | Resmetirom [New]Other 2 interventions
Group B: Farxiga (dapagliflozin) [Ongoing] | Resmetirom [New]Other 2 interventions
Group C: REZDIFFRA [Ongoing] | Actos (pioglitazone) [New]Other 2 interventions
Group D: REZDIFFRA [Ongoing] | Farxiga (dapagliflozin) [New]Other 2 interventions
Group E: Actos (pioglitazone) [New] | Resmetirom [New]Other 2 interventions
Group F: Farxiga (dapagliflozin) [New] | Resmetirom [New]Other 2 interventions

Trial outcomes

Primary outcomes

1

Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame
From First Dose of newly introduced medication up to 28 weeks
2

Number and Percentage of Participants With TEAEs by Maximum Severity

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.

Time frame
From First Dose of newly introduced medication up to 28 weeks
3

Number and Percentage of Participants With TEAEs by Relationship to Study Medication

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.

Time frame
From First Dose of newly introduced medication up to 28 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Madrigal Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: