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)

Non-Alcoholic Fatty Liver Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951219
• Other study ID #: MGL-3196-18
• Status: Recruiting
• Phase: Phase 3
• Start date: July 9, 2021
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: Madrigal Pharmaceuticals, Inc.
• Contact: Edward Chiang
• Phone: 267-520-0252
• Email: info[@]madrigalpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Resmetirom
Tablet

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Pinnacle Clinical Research - Austin	Austin	Texas
United States	Digestive Health Center of Louisiana	Baton Rouge	Louisiana
United States	Central Research Associates	Birmingham	Alabama
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Arizona Liver Health - Chandler	Chandler	Arizona
United States	East Valley Family Physicians	Chandler	Arizona
United States	Chicago Research Center	Chicago	Illinois
United States	Northwestern Memorial Physicians Group	Chicago	Illinois
United States	Platinum - Sterling Research Group - Springdale	Cincinnati	Ohio
United States	Premier Medical Group - Clarksville - Dunlop Lane	Clarksville	Tennessee
United States	Aventiv Research Columbus	Columbus	Ohio
United States	Dallas Research Center	Dallas	Texas
United States	Liver Center of Texas	Dallas	Texas
United States	The Liver Institute At Methodist Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Clarity Clinical Research	East Syracuse	New York
United States	South Texas Research Institute	Edinburg	Texas
United States	South Denver Gastroenterology - Swedish Medical Center Office	Englewood	Colorado
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	Gastrointestinal Associates & Endoscopy Center - Flowood	Flowood	Mississippi
United States	Covenant Research	Fort Myers	Florida
United States	Texas Digestive Disease Consultants	Fort Worth	Texas
United States	Fresno Clinical Research Center	Fresno	California
United States	Gastro One - Germantown Office - Wolf Park Drive	Germantown	Tennessee
United States	The Institute For Liver Health - Glendale	Glendale	Arizona
United States	Velocity Clinical Research, Hallandale Beach (MD Clinical)	Hallandale Beach	Florida
United States	Henderson Research Center	Henderson	Nevada
United States	Floridian Clinical Research	Hialeah	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Liver Associates of Texas	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Nature Coast Clinical Research - Inverness	Inverness	Florida
United States	Southern Therapy and Advanced Research	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Florida Research Institute	Lakewood Ranch	Florida
United States	Wasatch Peak Family Practice	Layton	Utah
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	National Research Institute - Los Angeles	Los Angeles	California
United States	Ruane Clinical Research Group	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Awasty Research Network	Marion	Ohio
United States	Tandem Clinical Research - New Orleans Area Site	Marrero	Louisiana
United States	Doctor's Hospital at Renaissance	McAllen	Texas
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	Catalina Research Institute	Montclair	California
United States	Diabetes and Endocrinology Consultants	Morehead City	North Carolina
United States	Salt Lake City Research Center	Murray	Utah
United States	Mount Sinai Health System	New York	New York
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Orlando Research Center	Orlando	Florida
United States	National Research Institute - Panorama City	Panorama City	California
United States	Plano Research Center	Plano	Texas
United States	Progressive Medical Research	Port Orange	Florida
United States	Bon Secours Liver Institute of Richmond	Richmond	Virginia
United States	National Clinical Research - Richmond	Richmond	Virginia
United States	Virginia Commonwealth University School of Medicine	Richmond	Virginia
United States	Pinnacle Clinical Research - San Antonio	San Antonio	Texas
United States	San Antonio Research Center	San Antonio	Texas
United States	Texas Liver Institute/American Research Corporation	San Antonio	Texas
United States	Texas Digestive Disease Consultants - San Marcos	San Marcos	Texas
United States	Covenant Research	Sarasota	Florida
United States	Liver Institute Northwest	Seattle	Washington
United States	The Villages Research Center	The Villages	Florida
United States	Kansas Medical Clinic - Gastroenterology	Topeka	Kansas
United States	Adobe Gastroenterology	Tucson	Arizona
United States	The Institute For Liver Health - Tucson	Tucson	Arizona
United States	Impact Research Institute	Waco	Texas
United States	Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center	Webster	Texas
United States	Iowa Diabetes Research	West Des Moines	Iowa
United States	San Fernando Valley Health Institute	West Hills	California
United States	Clinical Trials of America	West Monroe	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Madrigal Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of once daily, oral administration of resmetirom on the incidence of adverse events.		52 weeks
Secondary	Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline		16 weeks
Secondary	Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline		52 weeks
Secondary	Percent change in LDL-C from baseline		28 weeks