13 completed, 6 recruiting, 3 active not recruiting. 11 Phase 1, 5 Phase 2, 4 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 10, Recruiting 1 |
| Phase 2 | 5 | Recruiting 3, Completed 2 |
| Phase 3 | 4 | Active not recruiting 3, Completed 1 |
| Phase 4 | 2 | Recruiting 2 |
Follow resmetirom: new trials by email Literature Review of resmetirom trials Research Report on resmetirom
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis Rezdiffra, Resmetirom, ACTOS/pioglitazone - MASH - Metabolic Dysfunction-Associated Steatohepatitis | Phase 4 | Recruiting | Madrigal Pharmaceuticals, Inc. | 150 | 2026-10-07 | 2026-10-16 |
| Resmetirom in Patients With MASH and HFpEF Resmetirom, Placebo - MASH - Metabolic Dysfunction-Associated Steatohepatitis, Heart Failure With Preserved Ejection Fraction (HFPEF) | Phase 1 | Recruiting | Madrigal Pharmaceuticals, Inc. | 90 | 2026-09-01 | 2026-10-16 |
| Study of Resmetirom in Children and Adolescents With MASH Resmetirom - MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis | Phase 2 | Recruiting | Madrigal Pharmaceuticals, Inc. | 61 | 2026-08-01 | 2026-09-11 |
| A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV Resmetirom, Placebo Control - MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, HIV (Human Immunodeficiency Virus) | Phase 2 | Recruiting | Naga P. Chalasani | 120 | 2026-04-23 | 2026-07-30 |
| Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH Resmetirom, Placebo - MASH - Metabolic Dysfunction-Associated Steatohepatitis | Phase 2 | Recruiting | Madrigal Pharmaceuticals, Inc. | 120 | 2025-12-29 | 2026-08-26 |
| Resmiterom Efficacy & Safety in Patients With MASH Resmetirom - MASH - Metabolic Dysfunction-Associated Steatohepatitis | Phase 4 | Recruiting | Nabiqasim Industries (Pvt) Ltd | 165 | 2025-10-17 | 2025-12-03 |
| A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants Denifanstat, Resmetirom - Healthy | Phase 1 | Completed | Sagimet Biosciences Inc. | 40 | 2025-09-30 | 2026-01-23 |
| A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function 100 mg Resmetirom Tablet - Renal Impairment | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 28 | 2024-03-06 | 2025-10-14 |
| A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) Resmetirom, Placebo - NASH, Cirrhosis, Liver | Phase 3 | Active not recruiting | Madrigal Pharmaceuticals, Inc. | 845 | 2022-08-26 | 2026-07-08 |
| 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) Resmetirom - Non-Alcoholic Fatty Liver Disease | Phase 3 | Active not recruiting | Madrigal Pharmaceuticals, Inc. | 810 | 2021-07-09 | 2026-05-27 |
| A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients Placebo, Resmetirom - Non-Alcoholic Fatty Liver Disease | Phase 3 | Completed | Madrigal Pharmaceuticals, Inc. | 1343 | 2019-12-16 | 2023-09-05 |
| Drug Interaction Study of MGL-3196 With Clopidogrel MGL-3196, Clopidogrel - Healthy | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 20 | 2019-07-26 | 2020-12-28 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis MGL-3196, Placebo, Liver Biopsy - NASH - Nonalcoholic Steatohepatitis | Phase 3 | Active not recruiting | Madrigal Pharmaceuticals, Inc. | 1759 | 2019-03-28 | 2026-06-01 |
| Drug Interaction Study of MGL-3196 With Pioglitazone MGL-3196, Pioglitazone 15mg - Healthy | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 16 | 2018-11-09 | 2020-12-17 |
| Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects MGL-3196 - Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 87 | 2018-10-25 | 2023-10-05 |
| Bioavailability Study of MGL-3196 Tablets Compared to Capsules MGL-3196 Tablet, MGL-3196 Capsule - Healthy | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 16 | 2018-02-05 | 2019-09-18 |
| Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196 MGL-3196 - Healthy | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 8 | 2017-08-06 | 2017-12-19 |
| Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) MGL-3196 (resmetirom), Placebo - Heterozygous Familial Hypercholesterolemia | Phase 2 | Completed | Madrigal Pharmaceuticals, Inc. | 116 | 2017-02-23 | 2026-06-04 |
| Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) MGL-3196, Placebo - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Madrigal Pharmaceuticals, Inc. | 125 | 2016-10-18 | 2025-12-23 |
| Drug Interaction Study of MGL-3196 With Atorvastatin Atorvastatin, MGL-3196 - Healthy | Phase 1 | Completed | Madrigal Pharmaceuticals, Inc. | 14 | 2016-04-01 | 2016-08-30 |
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Non-alcoholic Fatty Liver Disease (5) · Fibrosis (4) · Dyslipidemias (2) · Hyperlipidemias (2) · Liver Cirrhosis (2) · Thyroid Hormone Resistance Syndrome (2) · Acquired Immunodeficiency Syndrome (1) · Liver Diseases (1) · Renal Insufficiency (1)
Madrigal Pharmaceuticals, Inc. (19) · Nabiqasim Industries (Pvt) Ltd (1) · Naga P. Chalasani (1) · Sagimet Biosciences Inc. (1)
United States (20) · Puerto Rico (4) · Canada (3) · Belgium (2) · France (2) · Germany (2) · Italy (2) · Spain (2) · United Kingdom (2) · Australia (1) · Austria (1) · Denmark (1) · Hungary (1) · Israel (1) · Mexico (1)
Rebecca Taub, MD (3) · Tom Hare (2) · Danielle Armas, MD (1) · Geoff Rezvani (1) · George Ate, MD (1) · Gerri Poss, MD (1) · Terry O'Reilly, MD (1) · Thomas Hare (1) · Tom Hare, MD (1) · Tom Hare, MS (1) · Uli Frevert, MD (1)
PMID 37786277, PMID 33860116, PMID 38324483, PMID 31727409, PMID 34329774, PMID 35331419, PMID 37845512, PMID 39250515, PMID 41127972, PMID 41142528, PMID 41895606, PMID 41953252
2016 (1)