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)
Active, not recruiting · Phase 3 · NCT04951219
Conditions: Non-Alcoholic Fatty Liver Disease
At a glance
- Research payments reported, 2025
- $17.5M
- U.S. investigators named
- 144
- Sites paid
- 139
- Planned or actual enrollment
- 810
About the trial
- Sponsor
- Madrigal Pharmaceuticals, Inc.
- Tested
- Resmetirom (drug)
- Dates
- Started 2021-07-09; completion 2027-04
- Results posted
- Not yet
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)
From ClinicalTrials.gov, last updated 2026-05-27. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Madrigal Pharmaceuticals reported $17.5M in research payments for this study in 2025 (3,121 payments).
Products named: Rezdiffra
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Whitfield L. Knapple, M.D. Specialist · North Little Rock, AR
- Alonzo D. Williams SR., M.D. Gastroenterology · Little Rock, AR
- Aimee G. Bachelier, N.D. Naturopaths · Tucson, AZ
- Anita Kohli, MD Infectious Disease · Chandler, AZ
- Ann C. Moore, FNP Nurse Practitioners · Glendale, AZ
- Sam Moussa Specialist · Tucson, AZ
- Randall J. Severance, M.D. Internal Medicine · Gilbert, AZ
- Elysa Shaw, M.D. Family Medicine · Phoenix, AZ
- Alaa Abousaif, MD Gastroenterology · Orange, CA
- Veeral H. Ajmera, M.D. Gastroenterology · San Diego, CA
- Walid S. Ayoub, M.D. Hepatology · West Hollywood, CA
- Maricor C. Grio, M.D. Pediatrics · Mission Hills, CA
- Bilal Hameed, M.D. Hepatology · San Francisco, CA
- Tarek I. Hassanein, M.D. Hepatology · Coronado, CA
- Stanley Hsia, M.D. Endocrinology & Diabetes · Los Angeles, CA
- Robert A. Jenders Internal Medicine · Torrance, CA
- Jeffrey London, MD Internal Medicine · West Hills, CA
- Edward A. Mena, M.D. Hepatology · Pasadena, CA
- Marina M. Roytman, M.D. Hepatology · Fresno, CA
- Peter Ruane, MD Infectious Disease · Los Angeles, CA
- Muhammad Y. Sheikh, M.D. Gastroenterology · Fresno, CA
- Liyun Yuan, M.D., PHD Hepatology · Los Angeles, CA
- Marcelo Kugelmas, M.D Gastroenterology · Englewood, CO
- Amanda C. Wieland, MD Hepatology · Aurora, CO
- Neha Agrawal, MD Hepatology · Jacksonville, FL
- Robert W. Barish, M.D. Gastroenterology · Ocala, FL
- Seth J. Baum, MD Cardiology · Boca Raton, FL
- Jorge R. Beato, MD Internal Medicine · Miami, FL
- Sureka Bollepalli, M.D. Pediatric Endocrinology · Tampa, FL
- Tawfik Chami, MD Gastroenterology · Zephyrhills, FL
- Beatriz Colon, MD Emergency Medicine · Orlando, FL
- Noureen Dhanani, NP Nurse Practitioners · The Villages, FL
- Paul A. Hellstern, M.D. Gastroenterology · Crystal River, FL
- Michael J. Koren, M.D. Cardiology · Gainesville, FL
- Guy W. Neff, MD, MBA Gastroenterology · Sarasota, FL
- Angela C. Okolie, M.D Internal Medicine · Clermont, FL
- Benoit C. Pineau, MD Gastroenterology · St. Augustine, FL
- Manuel E. Rodriguez, M.D. Gastroenterology · Bradenton, FL
- Torfay S. Roman, M.D. Hepatology · Orlando, FL
- Angel M. Rosario, MD Gastroenterology · Tampa, FL
- Jose L. Ruiz, M.D. General Practice · Cutler Bay, FL
- Beth E. Safirstein Neurology · Hallandale Beach, FL
- Mirel Sanchez, M.D. Family Medicine · Miami, FL
- William E. Sanchez, M.D. Internal Medicine · Hialeah, FL
- Eugene R. Schiff, MD Hepatology · Miami, FL
- Alexander White, MD Family Medicine · Daytona Beach, FL
- Aasim M. Sheikh, MD Gastroenterology · Marietta, GA
- Jeffrey M. Williams, MD Gastroenterology · Athens, GA
- David Fitz-patrick, M.D. Specialist · Honolulu, HI
- Anuj Bhargava, MD Endocrinology & Diabetes · West Des Moines, IA
- Amanda C. Cheung, M.D. Hepatology · Chicago, IL
- Steven Flamm, MD Gastroenterology · Chicago, IL
- Joseph L. Newberg, MD Emergency Medicine · La Porte, IN
- Shekhar K. Challa, MD Gastroenterology · Topeka, KS
- Winston Dunn, M.D. Gastroenterology · Kansas City, KS
- Harold E. Bays, MD Endocrinology & Diabetes · Louisville, KY
- Humberto I. Aguilar, M.D. Gastroenterology · Shreveport, LA
- Bal R. Bhandari, M.D. Specialist · Bastrop, LA
- Christopher J. Christensen, M.D. Gastroenterology · Baton Rouge, LA
- Molly B. Delk, MD Hepatology · New Orleans, LA
- Clarence Dunn, M.D. Specialist · West Monroe, LA
- Gary M. Reiss, MD Gastroenterology · Marrero, LA
- George Therapondos, MD Hepatology · New Orleans, LA
- Anita Krishnarao, M.D. Gastroenterology · Worcester, MA
- Michelle J. Lai, M.D. Hepatology · Boston, MA
- Arpan Mohanty, MD Gastroenterology · Boston, MA
- Paul Thuluvath, M.D. Gastroenterology · Baltimore, MD
- Humberto C. Gonzalez Gonzalez, M.D Gastroenterology · Detroit, MI
- Bradley L. Freilich, MD Gastroenterology · Kansas City, MO
- Brent A. Neuschwander-tetri, MD Gastroenterology · Saint Louis, MO
- Fredric G. Regenstein, MD Hepatology · Kansas City, MO
- Vonda G. Reeves, MD Gastroenterology · Flowood, MS
- Manal F. Abdelmalek, MD Gastroenterology · Durham, NC
- Andrew S. Delemos, MD Hepatology · Charlotte, NC
- Kathryn J. Lucas, MD Endocrinology & Diabetes · Morehead City, NC
- Cynthia A. Moylan, M.D. Internal Medicine · Durham, NC
- John E. Poulos, M.D. Gastroenterology · Fayetteville, NC
- Mavis N. Matsumoto, M.D. Internal Medicine · Henderson, NV
- Meena Bansal, MD Hepatology · New York, NY
- Robert C. Cupelo, M.D. Internal Medicine · East Syracuse, NY
- Amreen M. Dinani, M.D, FRCPC Gastroenterology · New York, NY
- Lincoln Hernandez, M.D. Internal Medicine · New York, NY
- Ira M. Jacobson, MD Gastroenterology · New York, NY
- Sonal Kumar, MD Gastroenterology · New York, NY
- Naim Alkhouri, MD Gastroenterology · Westlake, OH
- Samir Arora, M.D. Specialist · Powell, OH
- Na Li, MD Gastroenterology · Columbus, OH
- Mousab I. Tabbaa, MD Gastroenterology · Westlake, OH
- Victor Araya, MD Hepatology · Doylestown, PA
- Jaideep Behari, MD Gastroenterology · Pittsburgh, PA
- Dina L. Halegoua-de Marzio, M.D. Gastroenterology · Philadelphia, PA
- Grisell Ortiz Lasanta, MD Internal Medicine · San Juan, PR
- Jose E. Rivera-acosta, MD Gastroenterology · Sanjuan, PR
- David Fried, MD Internal Medicine · East Greenwich, RI
- Edward E. Kimbrough, MD Gastroenterology · Columbia, SC
- Don C. Rockey, MD Hepatology · Charleston, SC
- Blake A. Jones, MD Gastroenterology · Rapid City, SD
- Joseph F. Kosinski, MD Family Medicine · Clarksville, TN
- Jacqueline D. Milam, MD Internal Medicine · Clarksville, TN
- Saras Sharma, D.O. Gastroenterology · Nashville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Hilario Alvarado III, MD Family Medicine · San Antonio, TX
- Hanumantha R. Ancha, M.D. Gastroenterology · Waco, TX
- S M. Badiga, MD Gastroenterology · Weslaco, TX
- Maya Balakrishnan, MD Gastroenterology · Houston, TX
- Jennifer M. Bashour, M.D. Internal Medicine · Irving, TX
- Danielle K. Coulter, M.D. General Practice · San Antonio, TX
- Anthony Derencius, PA-C Physician Assistants · San Antonio, TX
- Dimple Patel Desai, MD Family Medicine · Weslaco, TX
- Reem H. Ghalib, MD Gastroenterology · Arlington, TX
- Nadege T. Gunn, M.D. Gastroenterology · Waco, TX
- Henry R. Herrera JR., M.D. Gastroenterology · Edinburg, TX
- David B. Huang, MD, PHD Infectious Disease · Houston, TX
- Prasun K. Jalal, M.D. Hepatology · Houston, TX
- Nirupama E. Jerome, DNP Nurse Practitioners · Austin, TX
- Thomas Kepczyk, M.D. Gastroenterology · San Marcos, TX
- Adnan Lakhani, M.D. Internal Medicine · Angleton, TX
- Eric J. Lawitz, M.D. Gastroenterology · San Antonio, TX
- William M. Lee, MD Hepatology · Dallas, TX
- Gregg H. Lucksinger, M.D. Family Medicine · Austin, TX
- Ravi S. Mani, M.D. Gastroenterology · Webster, TX
- Apurva A. Modi, M.D. Gastroenterology · Fort Worth, TX
- Abdullah Mubarak, MD Hepatology · Tyler, TX
- Mazen Noureddin, M.D. Gastroenterology · Houston, TX
- Jacqueline G. O'leary, MD, MPH Gastroenterology · Dallas, TX
- Mangesh R. Pagadala, M.D. Hepatology · Dallas, TX
- Robert S. Rahimi, M.D., M.S.C.R. Hepatology · Dallas, TX
- Michele D. Reynolds, M.D. Family Medicine · Dallas, TX
- Manuel J. Rodriguez, M.D. Internal Medicine · San Antonio, TX
- Madhavi Rudraraju, M.D. Hepatology · San Antonio, TX
- Shannan Tujios, M.D. Gastroenterology · Dallas, TX
- David W. Victor III, M.D. Hepatology · Houston, TX
- Michael R. Adams, MD Family Medicine · Sandy, UT
- Jeffery L. Degrauw, MD Family Medicine · Layton, UT
- Stephen H. Caldwell Gastroenterology · Charlottesville, VA
- Michael Fuchs, M.D. Gastroenterology · Richmond, VA
- Omer Khalid, M.D. Gastroenterology · North Chesterfield, VA
- Velimir A. Luketic, M.D. Gastroenterology · Richmond, VA
- Arun Sanyal, M.D. Gastroenterology · Richmond, VA
- John K. Scott, MD Family Medicine · Glen Allen, VA
- Mitchell L. Shiffman, MD Gastroenterology · Newport News, VA
- Steven D. Lidofsky, M.D. Hepatology · Burlington, VT
- Nicole Kim Hepatology · Seattle, WA
- Kris V. Kowdley, MD Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Institute for Liver Health II LLC $1.6M
- Pinnacle Clinical Research PLLC $914,503
- Delta Research PArtners of Bastrop LLC $635,081
- Houston Research Institute LLC $616,404
- Bon Secours Mercy Health Inc $608,613
- Kansas City Research Institute LLC $527,416
- South Texas Research Institute $511,582
- Arizona Liver Health $463,213
- Delta Research PArtners LLC $412,399
- Duke University $398,003
- Covenant Metabolic Specialists LLC $375,419
- Velocity Clinical Research Inc $349,985
- Mayo Clinic $346,160
- Adobe Clinical Research LLC $324,696
- Texas Digestive Disease Consultants PLLC $319,917
- California Liver Research Institute $303,490
- Louisiana Research Center LLC $294,594
- South Denver Gastroenterology PC $266,556
- Liver Center of Texas PLLC $243,341
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $227,102
- Gastroenterology Center of the Midsouth PLLC $196,053
- Jacksonville Center for Clinical Research $189,416
- Northwestern University $189,258
- Boston Medical Center, MA $188,779
- Gastro One $187,332
- Arkansas Gastroenterology PA $186,016
- Methodist Dallas Medical Center, TX $182,784
- University of Pittsburgh Physicians $182,095
- Florida Digestive Health Specialists LLP $171,022
- Pinnacle Clinical Research LLC $165,060
- Fundacion De Investigacion De Diego Inc $163,503
- University of Southern California $161,888
- Gastrointestinal Specialists of Georgia PC $155,863
- Apex Mobile Clinical Research LLC $152,309
- Medical University of South Carolina $149,028
- Baylor College of Medicine $145,933
- Gastroenterology Center of the Midsouth PLLC $144,023
- International Center for Research $143,972
- Virginia Commonwealth University $136,614
- Tampa Bay Medical Research Inc $135,115
- Kansas Medical Clinic PA $125,401
- Thomas Jefferson University $113,998
- Lucas Research Inc $111,068
- Ocala Gi Research LLC $105,361
- Fdi Clinical Research $102,800
- Summit Clinical Research LLC $97,316
- Dhr Health Institute for R&d $95,945
- Texas Clinical Research Institute LLC $95,636
- Wake Forest University Health Sciences $95,581
- International Center for Research LLC $95,020
- University of Texas Southwestern Medical Center $91,578
- Dallas VA Research Corporation $91,453
- Knowledge Research Center $87,642
- Digestive Research of Central Texas LLC $87,083
- St Louis University $85,963
- Hi Tech and Global Research LLC $84,346
- Aes Orlando $84,149
- Richmond Institute for Veterans Research $83,655
- Weill Medical College of Cornell University $82,858
- The Methodist Hospital Research Institute $82,559
- University of Kansas Medical Center Research Institute Inc $79,895
- Usdh Clinical Research LLC $77,872
- Crioh LLC $76,397
- Rush University Medical Center, IL $75,416
- Beth Israel Deaconess Medical Center, MA $75,272
- Saint PAul Place Specialists Inc $73,688
- The Ohio State University $70,920
- Tandem Clinical Research Gi LLC $70,458
- Adventhealth Orlando, FL $68,890
- St PAul Place Specialists Inc $66,892
- Latin Clinical Trial Center Inc $64,590
- Rapid City Medical Center LLP $64,166
- Mount Sinai School of Medicine $63,685
- Clinical Research Institute of Ohio LLC $61,794
- Floridian Clinical Research LLC $61,233
- Coastal Research Institute LLC $56,072
- The Administrators of the Tulane Educational Fund $53,996
- University of Virginia Medical Center, VA $53,430
- Aes the Villages $52,899
- Liver Center of Texas $51,263
- Colombia Digestive Health Research LLC $48,795
- Aes Salt Lake City $48,067
- Knowlege Research Center $47,613
- University of Miami $46,906
- California Liver Research Center $46,034
- Bon Secours-Richmond Community Hospital Incorporated $43,811
- Quality Medical Research PLLC $42,587
- University of Massachusetts $37,621
- Jacksonville Center for Clinical Research LTD $36,835
- Arkansas Gastroenterology $36,728
- University of Florida $34,665
- New York University School of Medicine $33,551
- Gi Select Health Research LLC $33,075
- Excel Medical Clinical Trials LLC $32,969
- Univ. of Vermont - Fletcher Allen Health Care, VT $32,802
- Gastrointestinal Specialists of Georgia $30,880
- Premier Medical Group PC $29,725
- University of Washington Medical Ctr, WA $29,481
- Aes San Antonio $29,195
- Aes Henderson $27,682
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.