A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Active, not recruiting · Phase 3 · NCT03900429
Conditions: NASH - Nonalcoholic Steatohepatitis
At a glance
- Research payments reported, 2025
- $8.1M
- U.S. investigators named
- 74
- Sites paid
- 58
- Planned or actual enrollment
- 1,759
About the trial
- Sponsor
- Madrigal Pharmaceuticals, Inc.
- Tested
- MGL-3196 (drug), Placebo (drug), Liver Biopsy (procedure)
- Dates
- Started 2019-03-28; completion 2028-01
- Results posted
- Not yet
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
From ClinicalTrials.gov, last updated 2026-06-01. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Madrigal Pharmaceuticals reported $8.1M in research payments for this study in 2025 (1,436 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
- Judy L. White, M.D. Neurology · Florala, AL
- Whitfield L. Knapple, M.D. Specialist · North Little Rock, AR
- Anita Kohli, MD Infectious Disease · Chandler, AZ
- Ann C. Moore, FNP Nurse Practitioners · Glendale, AZ
- Sam Moussa Specialist · Tucson, AZ
- Walid S. Ayoub, M.D. Hepatology · West Hollywood, CA
- Stanley Hsia, M.D. Endocrinology & Diabetes · Los Angeles, CA
- Paul Y. Kwo, M.D. Hepatology · Stanford, CA
- Jeffrey London, MD Internal Medicine · West Hills, CA
- Rohit Loomba, MD Internal Medicine · La Jolla, CA
- Muhammad Y. Sheikh, M.D. Gastroenterology · Fresno, CA
- Marcelo Kugelmas, M.D Gastroenterology · Englewood, CO
- Michelle P. Lai, PHARM.D., BCPS Pharmacists · Wilmington, DE
- Seth J. Baum, MD Cardiology · Boca Raton, FL
- Noureen Dhanani, NP Nurse Practitioners · The Villages, FL
- Paul A. Hellstern, M.D. Gastroenterology · Crystal River, FL
- Guy W. Neff, MD, MBA Gastroenterology · Sarasota, FL
- Angela C. Okolie, M.D Internal Medicine · Clermont, FL
- Manuel E. Rodriguez, M.D. Gastroenterology · Bradenton, FL
- Aasim M. Sheikh, MD Gastroenterology · Marietta, GA
- Justin R. Boike, MD Hepatology · Chicago, IL
- Mary Rinella, MD Gastroenterology · Chicago, IL
- Shekhar K. Challa, MD Gastroenterology · Topeka, KS
- Winston Dunn, M.D. Gastroenterology · Kansas City, KS
- 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
- Jared Magee, DO,MPH Gastroenterology · Bethesda, MD
- Michael J. Hafran, M.D. Family Medicine · East Lansing, MI
- Jeffrey A. London, MD Child & Adolescent Psychiatry · Troy, MI
- Bradley L. Freilich, MD Gastroenterology · Kansas City, MO
- Brent A. Neuschwander-tetri, MD Gastroenterology · Saint Louis, MO
- Brian B. Borg, MD, MHSC Gastroenterology · Jackson, MS
- Mark E. Wilson, MD Gastroenterology · Jackson, MS
- Alfred S. Barritt IV, MD Gastroenterology · Chapel Hill, NC
- Cynthia A. Moylan, M.D. Internal Medicine · Durham, NC
- John E. Poulos, M.D. Gastroenterology · Fayetteville, NC
- Claire Presswood Internal Medicine · Morehead City, NC
- Meena Bansal, MD Hepatology · New York, NY
- Sonal Kumar, MD Gastroenterology · New York, NY
- Naim Alkhouri, MD Gastroenterology · Westlake, OH
- Samir Arora, M.D. Specialist · Powell, OH
- Sridhar Guduri, M.D Allergy & Immunology · Dublin, OH
- Ravi V. Ravinuthala, M.D. Gastroenterology · Cincinnati, OH
- Grisell Ortiz Lasanta, MD Internal Medicine · San Juan, PR
- Jason L. Huffman, M.D. Gastroenterology · Knoxville, TN
- George W. James, MD Gastroenterology · Nashville, TN
- Joseph F. Kosinski, MD Family Medicine · Clarksville, TN
- Ziad H. Younes, M.D. Gastroenterology · Germantown, TN
- Victor Ankoma-sey, M.D. Gastroenterology · Houston, TX
- S M. Badiga, MD Gastroenterology · Weslaco, TX
- Jennifer M. Bashour, M.D. Internal Medicine · Irving, TX
- Dimple Patel Desai, MD Family Medicine · Weslaco, TX
- Johanna G. Hollweg, D.O. Gastroenterology · Jbsa Ft Sam Houston, TX
- Thomas Kepczyk, M.D. Gastroenterology · San Marcos, TX
- Eric J. Lawitz, M.D. Gastroenterology · San Antonio, TX
- Ravi S. Mani, M.D. Gastroenterology · Webster, TX
- Apurva A. Modi, M.D. Gastroenterology · Fort Worth, TX
- Mangesh R. Pagadala, M.D. Hepatology · Dallas, TX
- Rashmee Patil Hepatology · Mcallen, TX
- Rohit V. Puskoor, M.D. Internal Medicine · Fort Worth, TX
- Robert S. Rahimi, M.D., M.S.C.R. Hepatology · Dallas, TX
- Michele D. Reynolds, M.D. Family Medicine · Dallas, TX
- Madhavi Rudraraju, M.D. Hepatology · San Antonio, TX
- Daniel Santillano, MD Internal Medicine · San Antonio, TX
- Roberto Valledor, MD Family Medicine · Mission, TX
- Juan F. Gallegos-orozco, M.D. Hepatology · Salt Lake City, UT
- Stephen H. Caldwell Gastroenterology · Charlottesville, VA
- Michael Fuchs, M.D. Gastroenterology · Richmond, VA
- Arun Sanyal, M.D. Gastroenterology · Richmond, VA
- Mitchell L. Shiffman, MD Gastroenterology · Newport News, VA
- Kris V. Kowdley, MD Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Covenant Metabolic Specialists LLC $846,426
- Pinnacle Clinical Research PLLC $630,713
- Dhr Health Institute for R&d $610,432
- South Texas Research Institute $580,375
- Fresno Clinical Research Center $542,244
- The Institute for Liver Health II LLC $497,665
- Adobe Clinical Research LLC $423,644
- Duke University $337,558
- Florida Digestive Health Specialists LLP $238,133
- Kansas Medical Clinic PA $208,243
- Texas Digestive Disease Consultants PLLC $192,539
- Premier Medical Group PC $170,289
- Excel Medical Clinical Trials LLC $165,400
- Lucas Research Inc $153,430
- Gastrointestinal Associates PA $146,001
- Velocity Clinical Research Inc $143,586
- Kansas City Research Institute LLC $127,552
- Methodist Dallas Medical Center, TX $121,103
- Virginia Commonwealth University $118,159
- South Denver Gastroenterology PC $114,777
- Richmond Institute for Veterans Research $113,046
- Gastrointestinal Specialists of Georgia PC $111,724
- Cedars-Sinai Medical Center, CA $101,899
- Aventiv Research Inc $101,057
- Ochsner Medical Center Acute, LA $97,824
- Gia Clinical Trials LLC $93,551
- Fundacion De Investigacion De Diego Inc $76,809
- Gcga Physicians LLC $76,439
- Digestive Health Research LLC $73,824
- Tandem Clinical Research LLC $72,260
- University of California San Diego $69,755
- The Geneva Foundation $68,506
- St Louis University $53,724
- Gastroenterology Center of the Midsouth PLLC $49,003
- American Research Corporation $47,929
- Coastal Research Institute LLC $45,415
- Bd of Trus of the Leland Stanford Jr Univ $44,509
- Northwestern University $39,075
- Gastroenterology Center of the Midsouth PLLC $34,344
- Nature Coast Clinical Research $34,138
- Arkansas Gastroenterology PA $33,856
- San Fernando Valley Health Institute LLC $32,875
- Delta Research PArtners LLC $31,919
- University of Virginia Medical Center, VA $31,750
- Bon Secours Mercy Health Inc $25,879
- University of Kansas Medical Center Research Institute Inc $22,628
- The University of Chicago $21,802
- Unc School of Medicine $18,963
- University of Utah $15,975
- Liver Associates of Texas PA $13,525
- The Administrators of Tulane Edu Fund $13,503
- Weill Medical College of Cornell Univ $13,461
- Compass Research LLC $13,000
- Mount Sinai School of Medicine $11,546
- Beth Israel Deaconess Medical Center, MA $5,250
- Southern Therapy and Advanced Research LLC $2,048
- Aes the Villages $1,573
- Aes Dallas $1,144
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.