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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)

Sponsor
Madrigal Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04951219
Collaborator
(none)
1,000
Enrollment
70
Locations
3
Arms
16.8
Anticipated Duration (Months)
14.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 single-blind, 12-week lead-in treatment period. Only investigators and patients will be blinded to treatment assignment during the single-blind treatment period.
Primary Purpose:
Treatment
Official Title:
A 52-Week, Phase 3, Open-Label Extension Study, With a Single-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 :
Jul 9, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single-blind 80 mg Daily

Single-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52

Drug: Resmetirom
Tablet
Other Names:
  • MGL-3196

    		•
    Experimental: Single-blind 100 mg Daily

    Single-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52

    Drug: Resmetirom
    Tablet
    Other Names:
  • MGL-3196

    		•
    Experimental: Open-label 100 mg Daily

    Open-label resmetirom 100 mg for an additional 52 weeks

    Drug: Resmetirom
    Tablet
    Other Names:
  • MGL-3196

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events. [52 weeks]

    Secondary Outcome Measures

    1. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline [16 weeks]

    2. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline [52 weeks]

    3. Percent change in LDL-C from baseline [28 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must have participated in 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 the Extension study and provide written informed consent.

    • 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 with F2 or F3

    • NAS = 3, ballooning 0 with F2 or F3

    • NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)

    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

    Locations

    Site City State Country Postal Code
    1 Central Research Associates Birmingham Alabama United States 35205
    2 Arizona Liver Health - Chandler Chandler Arizona United States 85224
    3 East Valley Family Physicians Chandler Arizona United States 85224
    4 The Institute For Liver Health - Glendale Glendale Arizona United States 85306
    5 The Institute For Liver Health - Tucson Tucson Arizona United States 85711
    6 Adobe Gastroenterology Tucson Arizona United States 85712
    7 Arkansas Gastroenterology North Little Rock Arkansas United States 72117
    8 Fresno Clinical Research Center Fresno California United States 93720
    9 National Research Institute - Huntington Park Huntington Park California United States 90255
    10 Ruane Clinical Research Group Los Angeles California United States 90036
    11 National Research Institute - Los Angeles Los Angeles California United States 90057
    12 Catalina Research Institute Montclair California United States 91763
    13 National Research Institute - Panorama City Panorama City California United States 91402
    14 San Fernando Valley Health Institute West Hills California United States 91307
    15 South Denver Gastroenterology - Swedish Medical Center Office Englewood Colorado United States 80113
    16 Excel Medical Clinical Trials Boca Raton Florida United States 33434
    17 Velocity Clinical Research, Hallandale Beach (MD Clinical) Hallandale Beach Florida United States 33009
    18 Floridian Clinical Research Hialeah Florida United States 33016
    19 Nature Coast Clinical Research - Inverness Inverness Florida United States 34452
    20 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    21 Florida Research Institute Lakewood Ranch Florida United States 34211
    22 Miami Dade Medical Research Institute Miami Florida United States 33176
    23 Orlando Research Center Orlando Florida United States 32806
    24 Progressive Medical Research Port Orange Florida United States 32127
    25 Covenant Research Sarasota Florida United States 34240
    26 The Villages Research Center The Villages Florida United States 32162
    27 Gastrointestinal Specialists of Georgia Marietta Georgia United States 30060
    28 East-West Medical Research Institute Honolulu Hawaii United States 96814
    29 Chicago Research Center Chicago Illinois United States 60602
    30 Northwestern Memorial Physicians Group Chicago Illinois United States 60611
    31 Iowa Diabetes Research West Des Moines Iowa United States 50265
    32 Kansas Medical Clinic - Gastroenterology Topeka Kansas United States 66606
    33 L-MARC Research Center Louisville Kentucky United States 40213
    34 Digestive Health Center of Louisiana Baton Rouge Louisiana United States 70809
    35 Tandem Clinical Research - New Orleans Area Site Marrero Louisiana United States 70072
    36 Clinical Trials of America West Monroe Louisiana United States 71291
    37 Gastrointestinal Associates & Endoscopy Center - Flowood Flowood Mississippi United States 39232
    38 Southern Therapy and Advanced Research Jackson Mississippi United States 39216
    39 Kansas City Research Institute Kansas City Missouri United States 64131
    40 Henderson Research Center Henderson Nevada United States 89052
    41 Clarity Clinical Research East Syracuse New York United States 13057
    42 Mount Sinai Health System New York New York United States 10029
    43 Duke University Medical Center Durham North Carolina United States 27710
    44 Cumberland Research Associates Fayetteville North Carolina United States 28304
    45 Diabetes and Endocrinology Consultants Morehead City North Carolina United States 28557
    46 Platinum - Sterling Research Group - Springdale Cincinnati Ohio United States 45246
    47 Aventiv Research Columbus Columbus Ohio United States 43213
    48 Awasty Research Network Marion Ohio United States 43302
    49 Premier Medical Group - Clarksville - Dunlop Lane Clarksville Tennessee United States 37040
    50 Gastro One - Germantown Office - Wolf Park Drive Germantown Tennessee United States 38138
    51 Pinnacle Clinical Research - Austin Austin Texas United States 78746
    52 The Liver Institute At Methodist Dallas Dallas Texas United States 75203
    53 Dallas Research Center Dallas Texas United States 75234
    54 Liver Center of Texas Dallas Texas United States 75234
    55 South Texas Research Institute Edinburg Texas United States 78539
    56 Liver Associates of Texas Houston Texas United States 77030
    57 Doctor's Hospital at Renaissance McAllen Texas United States 78504
    58 Plano Research Center Plano Texas United States 75093
    59 Texas Liver Institute/American Research Corporation San Antonio Texas United States 78215
    60 Pinnacle Clinical Research - San Antonio San Antonio Texas United States 78229
    61 San Antonio Research Center San Antonio Texas United States 78229
    62 Texas Digestive Disease Consultants - San Marcos San Marcos Texas United States 78666
    63 Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center Webster Texas United States 77598
    64 Wasatch Peak Family Practice Layton Utah United States 84041
    65 Salt Lake City Research Center Murray Utah United States 84123
    66 Bon Secours Liver Institute of Richmond Richmond Virginia United States 23226
    67 National Clinical Research - Richmond Richmond Virginia United States 23294
    68 Virginia Commonwealth University School of Medicine Richmond Virginia United States 23298
    69 Liver Institute Northwest Seattle Washington United States 98105
    70 Fundacion de Investigacion de Diego San Juan Puerto Rico

    Sponsors and Collaborators

    • Madrigal Pharmaceuticals, Inc.

    Investigators

    • Study Director: Rebecca Taub, MD, Madrigal Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Madrigal Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04951219
    Other Study ID Numbers:
    • MGL-3196-18
    First Posted:
    Jul 6, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    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:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Aug 19, 2021