Evidence map›Paper›PMID 41021771›Full record

ArticleClinical and translational science2025

Pharmacokinetics and Safety of Pelacarsen, a GalNAc

Jing-He Yan, Amanda J Taylor, Timothy Clough, Elise Burmeister-Getz, Marketa Pazdirkova, Cesare Russo

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05026996 (A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Pelacarsen), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05026996 phase1completednot on this map

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

TypeinterventionalSponsorNovartis PharmaceuticalsRan2021 to 2022Enrolled17ConditionsHepatic ImpairmentArmsPelacarsen
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Pharmacokinetics and Safety of Pelacarsen, a GalNAcClinical and translational science · 2025
    Article
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

6 authors.

Jing-He YanNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USA.ORCID 0009-0005-1546-8137
Amanda J TaylorNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USA.ORCID 0009-0004-7720-9475
Timothy CloughNovartis Pharmaceuticals Corp., East Hanover, New Jersey, USA.ORCID 0009-0005-5215-0873
Elise Burmeister-GetzNovartis BioMedical Research, Emeryville, California, USA.ORCID 0000-0003-2716-2088
Marketa PazdirkovaNovartis, Prague, Czech Republic.
Cesare RussoNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-6387-7067

Funding

Novartis Pharma AG
6 · The paper itself

Abstract

Pelacarsen, an antisense oligonucleotide, directly inhibits plasma lipoprotein(a) production; however, it remains unknown whether hepatic impairment (HI) impacts its safety and pharmacokinetics. This single-dose, open-label, parallel-group, phase I study (NCT05026996) assessed the effect of mild HI on the pharmacokinetics, safety, and tolerability of pelacarsen. Participants (aged 18-75 years) with mild HI (n = 8; Child-Pugh Class A) or healthy controls (n = 9; matched for sex, age, and body weight) received a single subcutaneous injection of 80 mg pelacarsen. Pharmacokinetic parameters were determined using non-compartmental methods. Log-transformed pharmacokinetic parameters were analyzed using a statistical model with group and matching covariates as fixed effects. Least-squares geometric means for each group and geometric mean ratios between participants with mild HI and healthy controls were extracted. The geometric mean ratios for pelacarsen maximum observed concentration (C

Indexed as

AcetylgalactosamineOligonucleotides, AntisenseAdolescentAdultAgedArea Under CurveFemaleHumansInjections, SubcutaneousMaleMiddle AgedOligonucleotidesSeverity of Illness IndexYoung AdultAcetylgalactosamineOligonucleotidesOligonucleotides, Antisensepelacarsenantisense oligonucleotidehepatic impairmentLp(a)pelacarsenpharmacokineticsplasma lipoprotein(a)

Identifiers

PMID41021771
PMCPMC12478598

What OpenQuestion holds

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LicenceCC BY-NC
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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 OpenQuestion graph.