Evidence mapPaperPMID 41127972Full record

Trial reportAlimentary pharmacology & therapeutics2025

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.

Mazen Noureddin, Mary Rinella, Rebecca Taub, Dominic Labriola, Raul C Camacho, Naim Alkhouri, Rohit Loomba, Meena B Bansal

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03900429 (A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03900429 phase3active not recruitingnot on this map

A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

TypeinterventionalSponsorMadrigal Pharmaceuticals, Inc.Ran2019 to 2028Enrolled1,759ConditionsNASH - Nonalcoholic SteatohepatitisArmsMGL-3196, Placebo, Liver Biopsy
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mazen NoureddinHouston Methodist Hospital, Houston, Texas, USA.
Mary RinellaUniversity of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA.
Rebecca TaubMadrigal Pharmaceuticals, West Conshohocken, Pennsylvania, USA.
Dominic LabriolaMadrigal Pharmaceuticals, West Conshohocken, Pennsylvania, USA.
Raul C CamachoMadrigal Pharmaceuticals, West Conshohocken, Pennsylvania, USA.
Naim AlkhouriSummit Clinical Research, San Antonio, Texas, USA.ORCID https://orcid.org/0000-0001-9872-2391
Rohit LoombaMASLD Research Center, University of California at San Diego, La Jolla, California, USA.ORCID https://orcid.org/0000-0002-4845-9991
Meena B BansalIcahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID https://orcid.org/0000-0002-7501-2191

Funding

Madrigal Pharmaceuticals
6 · The paper itself

Abstract

backgroundMAESTRO-NASH, a randomised, double-blind, placebo-controlled, 54-month phase 3 trial evaluating the efficacy of resmetirom in patients with biopsy-confirmed metabolic-dysfunction associated steatohepatitis (MASH) and liver fibrosis achieved primary endpoints of MASH resolution with no worsening of fibrosis, and ≥ 1-stage improvement in fibrosis with no worsening of MASH at 52-weeks.

aimsThe effects of resmetirom (80 or 100 mg) versus placebo were evaluated on Week 52 histological and biomarker endpoints in relation to background treatment with sodium-glucose cotransporter 2 inhibitors (SGLT2i), GLP-1 receptor agonists (GLP-1 RA), and/or ≥ 5% weight loss at Week 52.

methodsAt baseline, 13%-17% of patients (all with type 2 diabetes mellitus [T2DM]) were on stable GLP-1 RA or SGLT2i therapy. Changes in liver histology, MRI-proton density fat fraction (MRI-PDFF), and liver stiffness were examined after 52 weeks of treatment.

resultsNo weight loss above baseline occurred with GLP-1 RA or SGLT2i therapy. SGLT2 and GLP-1 RA treated patients showed similar rates of MASH resolution and fibrosis improvement in combination with resmetirom as patients not on these therapies. Resmetirom-treated patients (100 mg) with weight loss (≥ 5%) compared with those with weight loss < 5% had higher rates of MASH resolution (56.6% vs. 33.8%), fibrosis improvement (40.6% vs. 31.5%), MRI-PDFF reduction (-69% vs. -46%), and liver stiffness reduction after 52 weeks of treatment (-4.6 kPa vs. -2.3 kPa).

conclusionsThe efficacy of resmetirom on multiple MASH endpoints was not impacted by background SGLT2i or GLP-1 RA treatment. Weight loss (≥ 5%) enhanced the efficacy of resmetirom.

trial registrationMAESTRO-NASH ClinicalTrials.gov number, NCT03900429.

Indexed as

Diabetes Mellitus, Type 2Fatty LiverGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsNon-alcoholic Fatty Liver DiseaseWeight LossAdultAgedDouble-Blind MethodFemaleHumansLiver CirrhosisMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeGlucagon-Like Peptide-1 Receptor AgonistsHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitorsfibrosis improvementGLP‐1 receptor agonistsMASH resolutionresmetiromweight loss

Identifiers

PMID41127972
PMCPMC12646629

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.