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) (NCT04951219)

🧪 Interventions in This Study

• Resmetirom (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. 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:
3. NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
4. NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
5. 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
6. 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 .

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (76 Sites)

Showing the first 25 of 76 sites.

• Central Research Associates — Birmingham, Alabama
• Arizona Liver Health - Chandler — Chandler, Arizona
• East Valley Family Physicians — Chandler, Arizona
• The Institute For Liver Health - Glendale — Glendale, Arizona
• The Institute For Liver Health - Tucson — Tucson, Arizona
• Adobe Gastroenterology — Tucson, Arizona
• Arkansas Gastroenterology — North Little Rock, Arkansas
• Fresno Clinical Research Center — Fresno, California
• National Research Institute - Huntington Park — Huntington Park, California
• Ruane Clinical Research Group — Los Angeles, California
• Cedars-Sinai Medical Center — Los Angeles, California
• National Research Institute - Los Angeles — Los Angeles, California
• National Research Institute - Panorama City — Panorama City, California
• San Fernando Valley Health Institute — West Hills, California
• South Denver Gastroenterology - Swedish Medical Center Office — Englewood, Colorado
• Excel Medical Clinical Trials — Boca Raton, Florida
• Covenant Research — Fort Myers, Florida
• Velocity Clinical Research, Hallandale Beach (MD Clinical) — Hallandale, Florida
• Floridian Clinical Research — Hialeah, Florida
• Nature Coast Clinical Research - Inverness — Inverness, Florida
• Jacksonville Center for Clinical Research — Jacksonville, Florida
• Florida Research Institute — Lakewood Rch, Florida
• Floridian Clinical Research — Miami Lakes, Florida
• Orlando Research Center — Orlando, Florida
• Progressive Medical Research — Port Orange, Florida

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Non-Alcoholic Fatty Liver Disease

• The Olmsted NAFLD Epidemiology Study (TONES) — Rochester, Minnesota
• Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis — Chula Vista, California
• Fructose and Liver Diseases in Youth: Help Them FLY — Edmonton, Alberta
• A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH — Arcadia, California
• Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease — New York, New York
• SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease — Chicago, Illinois

Explore by condition: All Non-Alcoholic Fatty Liver Disease clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.