Back to resultsA 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)
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Resmetirom
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, NASH, Hyperlipidemia, Resmetirom, Thyroid hormone receptor beta, Hepatic, Fibrosis, NASH resolution, Thyroid hormone receptor agonist, Cardiovascular, Dyslipidemia, Fatty liver disease, Nonalcoholic steatohepatitis
Eligibility Criteria
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.
Sites / Locations
- Central Research AssociatesRecruiting
- Arizona Liver Health - ChandlerRecruiting
- East Valley Family PhysiciansRecruiting
- The Institute For Liver Health - GlendaleRecruiting
- The Institute For Liver Health - TucsonRecruiting
- Adobe GastroenterologyRecruiting
- Arkansas GastroenterologyRecruiting
- Fresno Clinical Research CenterRecruiting
- National Research Institute - Huntington ParkRecruiting
- Ruane Clinical Research GroupRecruiting
- National Research Institute - Los AngelesRecruiting
- Catalina Research InstituteRecruiting
- National Research Institute - Panorama CityRecruiting
- San Fernando Valley Health InstituteRecruiting
- South Denver Gastroenterology - Swedish Medical Center OfficeRecruiting
- Excel Medical Clinical TrialsRecruiting
- Velocity Clinical Research, Hallandale Beach (MD Clinical)Recruiting
- Floridian Clinical ResearchRecruiting
- Nature Coast Clinical Research - InvernessRecruiting
- Jacksonville Center for Clinical ResearchRecruiting
- Florida Research InstituteRecruiting
- Miami Dade Medical Research InstituteRecruiting
- Orlando Research CenterRecruiting
- Progressive Medical ResearchRecruiting
- Covenant ResearchRecruiting
- The Villages Research CenterRecruiting
- Gastrointestinal Specialists of GeorgiaRecruiting
- East-West Medical Research InstituteRecruiting
- Chicago Research CenterRecruiting
- Northwestern Memorial Physicians GroupRecruiting
- Iowa Diabetes ResearchRecruiting
- Kansas Medical Clinic - GastroenterologyRecruiting
- L-MARC Research CenterRecruiting
- Digestive Health Center of LouisianaRecruiting
- Tandem Clinical Research - New Orleans Area SiteRecruiting
- Clinical Trials of AmericaRecruiting
- Gastrointestinal Associates & Endoscopy Center - FlowoodRecruiting
- Southern Therapy and Advanced ResearchRecruiting
- Kansas City Research InstituteRecruiting
- Henderson Research CenterRecruiting
- Clarity Clinical ResearchRecruiting
- Mount Sinai Health SystemRecruiting
- Duke University Medical CenterRecruiting
- Cumberland Research AssociatesRecruiting
- Diabetes and Endocrinology ConsultantsRecruiting
- Platinum - Sterling Research Group - SpringdaleRecruiting
- Aventiv Research ColumbusRecruiting
- Awasty Research NetworkRecruiting
- Premier Medical Group - Clarksville - Dunlop LaneRecruiting
- Gastro One - Germantown Office - Wolf Park DriveRecruiting
- Pinnacle Clinical Research - AustinRecruiting
- The Liver Institute At Methodist DallasRecruiting
- Dallas Research CenterRecruiting
- Liver Center of TexasRecruiting
- South Texas Research InstituteRecruiting
- Liver Associates of TexasRecruiting
- Doctor's Hospital at RenaissanceRecruiting
- Plano Research CenterRecruiting
- Texas Liver Institute/American Research CorporationRecruiting
- Pinnacle Clinical Research - San AntonioRecruiting
- San Antonio Research CenterRecruiting
- Texas Digestive Disease Consultants - San MarcosRecruiting
- Texas Digestive Disease Consultants - Bay Area Houston Endoscopy CenterRecruiting
- Wasatch Peak Family PracticeRecruiting
- Salt Lake City Research CenterRecruiting
- Bon Secours Liver Institute of RichmondRecruiting
- National Clinical Research - RichmondRecruiting
- Virginia Commonwealth University School of MedicineRecruiting
- Liver Institute NorthwestRecruiting
- Fundacion de Investigacion de DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Single-blind 80 mg Daily
Single-blind 100 mg Daily
Open-label 100 mg Daily
Arm Description
Single-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Single-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Open-label resmetirom 100 mg for an additional 52 weeks
Outcomes
Primary Outcome Measures
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
Secondary Outcome Measures
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Percent change in LDL-C from baseline
Full Information
NCT ID
NCT04951219
First Posted
June 18, 2021
Last Updated
October 18, 2022
Sponsor
Madrigal Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04951219
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Madrigal Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
NAFLD, NASH, Hyperlipidemia, Resmetirom, Thyroid hormone receptor beta, Hepatic, Fibrosis, NASH resolution, Thyroid hormone receptor agonist, Cardiovascular, Dyslipidemia, Fatty liver disease, Nonalcoholic steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-blind 80 mg Daily
Arm Type
Experimental
Arm Description
Single-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Arm Title
Single-blind 100 mg Daily
Arm Type
Experimental
Arm Description
Single-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Arm Title
Open-label 100 mg Daily
Arm Type
Experimental
Arm Description
Open-label resmetirom 100 mg for an additional 52 weeks
Intervention Type
Drug
Intervention Name(s)
Resmetirom
Other Intervention Name(s)
MGL-3196
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Time Frame
16 weeks
Title
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Time Frame
52 weeks
Title
Percent change in LDL-C from baseline
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Chiang
Phone
267-520-0252
Email
info@madrigalpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Taub, MD
Organizational Affiliation
Madrigal Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Arizona Liver Health - Chandler
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
East Valley Family Physicians
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
The Institute For Liver Health - Glendale
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
The Institute For Liver Health - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Adobe Gastroenterology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Ruane Clinical Research Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
National Research Institute - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
National Research Institute - Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
San Fernando Valley Health Institute
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
South Denver Gastroenterology - Swedish Medical Center Office
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Velocity Clinical Research, Hallandale Beach (MD Clinical)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Floridian Clinical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Nature Coast Clinical Research - Inverness
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Orlando Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Covenant Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
The Villages Research Center
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Northwestern Memorial Physicians Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Iowa Diabetes Research
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Kansas Medical Clinic - Gastroenterology
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Digestive Health Center of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Tandem Clinical Research - New Orleans Area Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Clinical Trials of America
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Gastrointestinal Associates & Endoscopy Center - Flowood
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Southern Therapy and Advanced Research
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Henderson Research Center
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Clarity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Cumberland Research Associates
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Diabetes and Endocrinology Consultants
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Platinum - Sterling Research Group - Springdale
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Aventiv Research Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Awasty Research Network
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Premier Medical Group - Clarksville - Dunlop Lane
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Gastro One - Germantown Office - Wolf Park Drive
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Pinnacle Clinical Research - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
The Liver Institute At Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Dallas Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Liver Center of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Liver Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Doctor's Hospital at Renaissance
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Plano Research Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Texas Liver Institute/American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Pinnacle Clinical Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
San Antonio Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Texas Digestive Disease Consultants - San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Salt Lake City Research Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
National Clinical Research - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Virginia Commonwealth University School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madrigal Investigator
12. IPD Sharing Statement
Learn more about this trial
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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