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MGL-3196

DRUG9 trials

Sponsors

Madrigal Pharmaceuticals, Inc.

Conditions

Cirrhosis, LiverHealthyHepatic ImpairmentHeterozygous Familial HypercholesterolemiaNASH - Nonalcoholic SteatohepatitisNon-alcoholic Steatohepatitis

Phase 1

Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin
CompletedNCT02542969
Madrigal Pharmaceuticals, Inc.Healthy
Start: 2015-09-30End: 2015-10-31Updated: 2022-09-02
Drug Interaction Study of MGL-3196 With Atorvastatin
CompletedNCT02749578
Madrigal Pharmaceuticals, Inc.Healthy
Start: 2016-04-30End: 2016-05-31Updated: 2016-08-30
Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196
CompletedNCT03220165
Madrigal Pharmaceuticals, Inc.Healthy
Start: 2017-08-06End: 2017-09-03Updated: 2017-12-19
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
CompletedNCT04643795
Madrigal Pharmaceuticals, Inc.Cirrhosis, Liver, Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Start: 2018-10-25End: 2021-08-04Updated: 2023-10-05
Drug Interaction Study of MGL-3196 With Pioglitazone
CompletedNCT04671056
Madrigal Pharmaceuticals, Inc.Healthy
Start: 2018-11-09End: 2019-01-05Updated: 2020-12-17
Drug Interaction Study of MGL-3196 With Clopidogrel
CompletedNCT04671069
Madrigal Pharmaceuticals, Inc.Healthy
Start: 2019-07-26End: 2019-09-14Updated: 2020-12-28

Phase 2

Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
CompletedNCT02912260
Madrigal Pharmaceuticals, Inc.Non-alcoholic Steatohepatitis
Start: 2016-10-18End: 2021-11-23Updated: 2025-12-23
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia
Active, not recruitingNL-OMON45499
Madrigal Pharmaceuticals, Inc.Heterozygous Familial Hypercholesterolemia
Start: 2017-04-19Target: 26Updated: 2024-02-28

Phase 3

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Active, not recruitingNCT03900429
Madrigal Pharmaceuticals, Inc.NASH - Nonalcoholic Steatohepatitis
Start: 2019-03-28End: 2028-01-31Updated: 2024-02-20

Related Papers

Efficacy of tirzepatide, lanifibranor, and resmetirom in metabolic dysfunction-associated steatotic liver disease: a meta-analysis of high-quality randomized controlled trials.
2026-03-31
Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH Trial.
2025-10-231 citations
NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.
2025-01-019 citations
Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction–associated steatohepatitis (MASH) and fibrosis
Hepatology2024-09-0623 citations
A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis
New England Journal of Medicine2024-02-071357 citations
Relationship of non-invasive measures with histological response in patients with nonalcoholic steatohepatitis and fibrosis: 52-week data from the Phase 3 MAESTRO-NASH trial
Zeitschrift für Gastroenterologie2024-01-01
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial.
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Design of the phase 3 <scp>MAESTRO</scp> clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis
Alimentary Pharmacology & Therapeutics2023-10-0271 citations
UEG Week 2023 Oral Presentations
United European Gastroenterology Journal2023-10-011 citations
Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life.
2021-07-2751 citations
Effects of Resmetirom on Noninvasive Endpoints in a 36‐Week Phase 2 Active Treatment Extension Study in Patients With NASH
Hepatology Communications2021-01-04176 citations
Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
2019-11-11545 citations
P1521In a 36-week placebo-controlled phase 2 trial in patients with non-alcoholic steatohepatitis (NASH), treatment with MGL-3196 (resmetirom) significantly reduces atherogenic lipoprotein particles
European Heart Journal2019-10-011 citations