Evidence mapPaperPMID 37845512Full record

Trial reportNature medicine2023

Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial.

Stephen A Harrison, Rebecca Taub, Guy W Neff, K Jean Lucas, Dominic Labriola, Sam E Moussa, Naim Alkhouri, Mustafa R Bashir

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04197479 (A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom), which is not on this map. Cited by 206 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
206citing papers in PubMed, 7 pooled it
77.0field-weighted citation impact, top 1% of its field
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.

NCT04197479 phase3completednot on this map

A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)

TypeinterventionalSponsorMadrigal Pharmaceuticals, Inc.Ran2019 to 2023Enrolled1,343ConditionsNon-Alcoholic Fatty Liver DiseaseArmsPlacebo, Resmetirom
3 · Its place in the literature

Who cites it

206 citing papers in PubMed, 7 syntheses or guidelines pooled it, 357 citations in OpenAlex.

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146 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Stephen A HarrisonPinnacle Clinical Research, San Antonio, TX, USA. Stephenharrison87@gmail.com.ORCID 0000-0001-8285-2204
Rebecca TaubMadrigal Pharmaceuticals, Conshohocken, PA, USA.
Guy W NeffCovenant Metabolic Specialists, Sarasota, FL, USA.
K Jean LucasLucas Research, Morehead City, NC, USA.
Dominic LabriolaMadrigal Pharmaceuticals, Conshohocken, PA, USA.
Sam E MoussaUniversity of Arizona for Medical Sciences, Tucson, AZ, USA.
Naim AlkhouriArizona Liver Health, Tucson, AZ, USA.
Mustafa R BashirDuke University Medical Center, Durham, NC, USA.
Madrigal Pharmaceuticals (United States) · USArizona Liver Health · USBanner - University Medical Center Tucson · USDuke Medical Center · USLucas Research · USPinnacle Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. MAESTRO-NAFLD-1 was a 52-week randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety of resmetirom in adults with nonalcoholic fatty liver disease and presumed NASH. Patients were randomized to three double-blind arms (100 mg resmetirom (n = 325), 80 mg resmetirom (n = 327) or placebo (n = 320)) or open-label 100 mg resmetirom (n = 171). The primary end point was incidence of treatment-emergent adverse events (TEAEs) over 52 weeks and key secondary end points were LDL-C, apoB, triglycerides (over 24 weeks), hepatic fat (over 16 and 52 weeks) and liver stiffness (over 52 weeks). Resmetirom was safe and well tolerated. TEAEs occurred in 86.5% (open-label 100 mg resmetirom), 86.1% (100 mg resmetirom), 88.4% (80 mg resmetirom) and 81.8% (placebo) of patients. TEAEs in excess of placebo included diarrhea and nausea at the initiation of treatment. Key secondary end points included least square means difference from placebo at 80 mg, 100 mg resmetirom: LDL-C (-11.1%, -12.6%), apoB (-15.6%, -18.0%), triglycerides (-15.4%, -20.4%), 16-week hepatic fat (-34.9%, -38.6%), (P < 0.0001) and liver stiffness (-1.02, -1.70) and 52-week hepatic fat (-28.8, -33.9). These findings demonstrate resmetirom was safe and well tolerated in adults with presumed NASH, supporting a role for further clinical development. (ClinicalTrials.gov identifier NCT04197479 ).

Indexed as

Non-alcoholic Fatty Liver DiseaseAdultApolipoproteins BCholesterol, LDLDouble-Blind MethodHumansLiverPyridazinesTreatment OutcomeTriglyceridesUracilApolipoproteins BCholesterol, LDLPyridazinesresmetiromTriglyceridesUracil

Identifiers

PMID37845512
PMCPMC10667098
OpenAlexW4387666937

What Socratic holds

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LicenceCC BY
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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.