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A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

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ClinicalTrials.gov Identifier: NCT04951219
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : December 4, 2023
Sponsor:
Information provided by (Responsible Party):
Madrigal Pharmaceuticals, Inc.

Study Description
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Brief Summary:
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Drug: Resmetirom Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Select patients will be randomized in 1:1 manner to a double-blind, 12-week lead-in treatment period. Only investigators, patients, and the Sponsor will be blinded to treatment assignment during the double-blind treatment period.
Primary Purpose: Treatment
Official Title: A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
Actual Study Start Date : July 9, 2021
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Double-blind 80 mg Daily
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
 Drug: Resmetirom
Tablet
Other Name: MGL-3196
Experimental: Double-blind 100 mg Daily
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
 Drug: Resmetirom
Tablet
Other Name: MGL-3196
Experimental: Open-label
For patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for an additional 52 weeks (ie, 52 weeks in MGL-3196-14 and 104 weeks in MGL-3196-18).
 Drug: Resmetirom
Tablet
Other Name: MGL-3196
Experimental: Open-Label 80 mg
For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for 104 weeks
 Drug: Resmetirom
Tablet
Other Name: MGL-3196
Experimental: Open Label 100 mg
For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
 Drug: Resmetirom
Tablet
Other Name: MGL-3196
Experimental: Open-Label 40 mg
For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for 104 weeks
 Drug: Resmetirom
Tablet
Other Name: MGL-3196


Outcome Measures
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Primary Outcome Measures :
  1. The effect of once daily, oral administration of resmetirom on the incidence of adverse events. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline [ Time Frame: 16 weeks ]
  2. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline [ Time Frame: 52 weeks ]
  3. Percent change in LDL-C from baseline [ Time Frame: 28 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent.

  • For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results:

    • NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
    • NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
    • Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD <12, albumin ≥3.2, and bilirubin <2
  • For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score <8) NASH cirrhosis (including minimal decompensation) and MELD <15 unless MELD >=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE .

Exclusion Criteria:

  • A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1.
  • Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study.
  • Chronic liver diseases
  • Has an active autoimmune 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 patient, or interfere with the study outcomes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951219


Contacts
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Contact: Edward Chiang 267-520-0252 info@madrigalpharma.com

Locations
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Sponsors and Collaborators
Madrigal Pharmaceuticals, Inc.
Investigators
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Study Director: Rebecca Taub, MD Madrigal Pharmaceuticals, Inc.
More Information
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Responsible Party: Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04951219    
Other Study ID Numbers: MGL-3196-18
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: December 4, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madrigal Pharmaceuticals, Inc.:
NAFLD
NASH
Hyperlipidemia
Resmetirom
Thyroid hormone receptor beta
Hepatic
Fibrosis
 NASH resolution
Thyroid hormone receptor agonist
Cardiovascular
Dyslipidemia
Fatty liver disease
Nonalcoholic steatohepatitis
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases