Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial
Abstract
Background Non-alcoholic steatohepatitis (NASH) is characterised by hepatic steatosis, inflammation, hepatocellular injury, and progressive liver fibrosis. Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity. We aimed to assess the safety and efficacy of resmetirom in patients with NASH.Methods MGL-3196-05 was a 36-week randomised, double-blind, placebo-controlled study at 25 centres in the USA. Adults with biopsy confirmed NASH (fibrosis stages 1-3) and hepatic fat fraction of at least 10% at baseline when assessed by MRI-proton density fat fraction (MRI-PDFF) were eligible. Patients were randomly assigned 2:1 by a computer-based system to receive resmetirom 80 mg or matching placebo, orally once a day. Serial hepatic fat measurements were obtained at weeks 12 and 36, and a second liver biopsy was obtained at week 36. The primary endpoint was relative change in MRI-PDFF assessed hepatic fat compared with placebo at week 12 in patients who had both a baseline and week 12 MRI-PDFF. This trial is registered with ClinicalTrials.gov, number NCT02912260.Findings 348 patients were screened and 84 were randomly assigned to resmetirom and 41 to placebo at 18 sites in the USA. Resmetirom-treated patients (n=78) showed a relative reduction of hepatic fat compared with placebo (n=38) at week 12 (-32·9% resmetirom vs -10·4% placebo; least squares mean difference -22·5%, 95% CI -32·9 to -12·2; p<0·0001) and week 36 (-37·3% resmetirom [n=74] vs -8·5 placebo [n=34]; -28·8%, -42·0 to -15·7; p<0·0001). Adverse events were mostly mild or moderate and were balanced between groups, except for a higher incidence of transient mild diarrhoea and nausea with resmetirom.Interpretation Resmetirom treatment resulted in significant reduction in hepatic fat after 12 weeks and 36 weeks of treatment in patients with NASH. Further studies of resmetirom will allow assessment of safety and effectiveness of resmetirom in a larger number of patients with NASH with the possibility of documenting associations between histological effects and changes in non-invasive markers and imaging.Funding Madrigal Pharmaceuticals.
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Resmetirom reduced hepatic fat content (assessed via MRI-PDFF) after 12 and 36 weeks of treatment with positive effects on lipid profiles.
“The Thyroid Hormone Receptor Beta (THR‐B) Agonist Resmetirom (MGL‐3196) reduced hepatic fat content (assessed via MRI‐PDFF) after 12 and 36 weeks of treatment with positive effects on lipid profiles [60].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [60]
A relative reduction in MRI-PDFF-measured liver lipid content of > -30% has been shown to predict MASH resolution in several studies.
“While a relative reduction in MRI-PDFF-measured liver lipid content of > -30% has been shown to predict MASH resolution in several studies, 262,268”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [268]
Resmetirom could potentially reduce hepatosteatosis and NASH.
“Resmetirom (MGL-3196), another liver-specific THRβ agonist, was used in humans for the treatment of NASH in a multicenter RCT; it was found to decrease hepatic fat content after 12 and 36 weeks and could potentially reduce hepatosteatosis and NASH (81).”
From Emerging Therapies in Hypothyroidism (2024) · cites this paper as [81]
In a multicenter randomized controlled trial in humans, resmetirom (MGL-3196) decreased hepatic fat content after 12 and 36 weeks.
“Resmetirom (MGL-3196), another liver-specific THRβ agonist, was used in humans for the treatment of NASH in a multicenter RCT; it was found to decrease hepatic fat content after 12 and 36 weeks and could potentially reduce hepatosteatosis and NASH (81).”
From Emerging Therapies in Hypothyroidism (2024) · cites this paper as [81]
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Brennan, P. N., The University of Edinburgh, C. F. R. M., NHS Tayside, N. H. A. M. S., The University of Dundee, D. O. M. A. C. M., Dillon, J. F., NHS Tayside, N. H. A. M. S., The University of Dundee, D. O. M. A. C. M., McCrimmon, R., NHS Tayside, N. H. A. M. S., & The University of Dundee, D. O. M. A. C. M. (2022) · European Endocrinology · doi:10.17925/ee.2022.18.2.148 · Cited by 3 · see citing works
- Authors
- Harrison, S. A., Bashir, M. R., Guy, C. D., Zhou, R., Moylan, C. A., Frias, J. P., Alkhouri, N., Bansal, M. B., Baum, S., Neuschwander-Tetri, B. A., Taub, R., & Moussa, S. E.
- Affiliations
- University of Oxford (GB)
- Duke University (US)
- Medpace (United States) (US)
- The University of Texas at San Antonio Health Science Center (US)
- Icahn School of Medicine at Mount Sinai (US)
- Florida Atlantic University (US)
- Madrigal Pharmaceuticals (United States) (US)
- University of Arizona (US)
- Corresponding author
- Harrison, Stephen A
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2019-11
- Volume
- 394
- Issue
- 10213
- Pages
- 2012-2024
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2985579744
- Cited by
- 802
- References
- 31
- Citations by year
- 2026: 96 · 2025: 171 · 2024: 142 · 2023: 124 · 2022: 92 · 2021: 102 · 2020: 70 · 2019: 4
- FWCI
- 51.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (U01DK130177)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Keywords
- resmetirom, nonalcoholic steatohepatitis, thyroid hormone receptor beta agonist, hepatic steatosis, hepatic fat fraction, liver fibrosis, liver biopsy, proton density fat fraction, drug safety, drug efficacy, NASH treatment, lipotoxicity, phase 2
- MeSH terms
- Adult, Alanine Transaminase, Diarrhea, Double-Blind Method, Female, Humans, Inflammation, Lipids, Liver, Liver Cirrhosis, Magnetic Resonance Imaging, Male, Middle Aged, Nausea, Pyridazines, Uracil, Biomarkers, Thyroid Hormone Receptors beta, Non-alcoholic Fatty Liver Disease
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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