Evidence map›Paper›PMID 36866389›Full record

ArticleJHEP reports : innovation in hepatology2023

Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial.

Elizabeth A Brown, Anne Minnich, Arun J Sanyal, Rohit Loomba, Shuyan Du, John Schwarz, Richard L Ehman, Morten Karsdal, Diana J Leeming, Giovanni Cizza and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JHEP reports : innovation in hepatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03486899 (A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT03486899 phase2completednot on this map

A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

TypeinterventionalSponsorBristol-Myers SquibbRan2018 to 2021Enrolled197ConditionsLiver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic SteatohepatitisArmsBMS-986036, Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  6. Exploring Cirrhosis: Insights into Advances in Therapeutic Strategies.International journal of molecular sciences · 2025
    Review
  7. FGF-based drug discovery: advances and challenges.Nature reviews. Drug discovery · 2025
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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

11 authors at 5 institutions in 2 countries.

Elizabeth A BrownBristol Myers Squibb, Princeton, NJ, USA.
Anne MinnichBristol Myers Squibb, Princeton, NJ, USA.
Arun J SanyalVirginia Commonwealth University, Richmond, VA, USA.
Rohit LoombaUniversity of California, San Diego, San Diego, CA, USA.
Shuyan DuBristol Myers Squibb, Princeton, NJ, USA.
John SchwarzBristol Myers Squibb, Princeton, NJ, USA.
Richard L EhmanMayo Clinic College of Medicine, Rochester, MN, USA.
Morten KarsdalNordic Bioscience, Biomarkers & Research, Herlev, Denmark.
Diana J LeemingNordic Bioscience, Biomarkers & Research, Herlev, Denmark.
Giovanni CizzaBristol Myers Squibb, Princeton, NJ, USA.
Edgar D CharlesBristol Myers Squibb, Princeton, NJ, USA.
Bristol-Myers Squibb (United States) · USNordic Bioscience (Denmark) · DKMayo Clinic · USUniversity of California San Diego · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background & Aims: FALCON 1 was a phase IIb study of pegbelfermin in patients with non-alcoholic steatohepatitis (NASH) and stage 3 fibrosis. This FALCON 1 Methods: Blood-based composite fibrosis scores, blood-based biomarkers, and imaging biomarkers were evaluated for patients with available data from FALCON 1 at baseline through week 24. SomaSignal tests assessed protein signatures of NASH steatosis, inflammation, ballooning, and fibrosis in blood. Linear mixed-effect models were fit for each biomarker. Correlations and concordance were assessed between blood-based biomarkers, imaging, and histological metrics. Results: At week 24, pegbelfermin significantly improved blood-based composite fibrosis scores (ELF, FIB-4, APRI), fibrogenesis biomarkers (PRO-C3 and PC3X), adiponectin, CK-18, hepatic fat fraction measured by MRI-proton density fat fraction, and all four SomaSignal NASH component tests. Correlation analyses between histological and non-invasive measures identified four main categories: steatosis/metabolism, tissue injury, fibrosis, and biopsy-based metrics. Concordant and discordant effects of pegbelfermin on the primary endpoint Conclusions: Pegbelfermin improved NASH-related biomarkers most consistently through improvement of liver steatosis, though biomarkers of tissue injury/inflammation and fibrosis were also improved. Concordance analysis shows that non-invasive assessments of NASH support and exceed the improvements detected by liver biopsy, suggesting that greater consideration should be given to the totality of available data when evaluating the efficacy of NASH therapeutics. Clinical trial number: Post hoc analysis of NCT03486899. Impact and implications: FALCON 1 was a study of pegbelfermin

Indexed as

ALT, alanine aminotransferaseAPRI, AST-to-platelet ratio indexAST, aspartate aminotransferaseCK-18 M30, caspase-cleaved cytokeratin 18ELF, enhanced liver fibrosisFGF21, fibroblast growth factor 21FIB-4, fibrosis-4 indexfibroblast growth factor 21liver fibrosisMRE, magnetic resonance elastographyMRI-PDFF, MRI-proton density fat fractionNAFLD, non-alcoholic fatty liver diseaseNASH, non-alcoholic steatohepatitisNAS, NAFLD activity scorenon-alcoholic steatohepatitisP3NP, procollagen-3 N-terminal propeptidePC3X, crosslinked ADAMTS-2-released N-terminal type III collagen propeptidePGBF, pegbelferminprecirrhotic NASHPRO-C3, monomeric ADAMTS-2-released N-terminal type III collagen propeptideSomaSignalsteatosisT2D, type 2 diabetesTG, triglyceridesTIMP-1, tissue inhibitor of metalloproteinases type 1

Identifiers

PMID36866389
PMCPMC9971179
OpenAlexW4313655957

What OpenQuestion 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 OpenQuestion graph.