Evidence map›Paper›PMID 38949758›Full record

Trial reportDrugs in R&D2024

A Randomized, Open-Label, Phase I, Single-Dose Study of Antisense Oligonucleotide, Vupanorsen, in Chinese Adults with Elevated Triglycerides.

Xiaojie Wu, Jicheng Yu, Beikang Ge, Jeffrey Wang, Xiaoran Han, Chunye Zhang, Xiaomeng Mao, Hindu Kalluru, Candace Bramson, Steven G Terra and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drugs in R&D, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04916795 (A PHASE 1, RANDOMIZED, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF VUPANORSEN ADMINISTERED SUBCUTANEOUSLY TO HEALTHY CHINESE ADULTS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04916795 phase1completednot on this map

A phase 1, randomized, open-label, single dose study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of vupanorsen administered subcutaneously to healthy chinese adults

TypeinterventionalSponsorPfizerRan2021 to 2021Enrolled18ConditionsHealthyArmsVupanorsen
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

Xiaojie WuPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jicheng YuPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Beikang GePfizer Pharmaceutical Ltd., Development China, 9/F, Tower B, Minmetals Plaza, No. 3-7 North Chaoyangmen Avenue, Dongcheng District, Beijing, China. Beikang.Ge@pfizer.com.
Jeffrey WangPfizer Pharmaceutical Ltd., Development China, 9/F, Tower B, Minmetals Plaza, No. 3-7 North Chaoyangmen Avenue, Dongcheng District, Beijing, China.
Xiaoran HanPfizer (China), Research and Development Co., Ltd., Shanghai, China.
Chunye ZhangPfizer (China), Research and Development Co., Ltd., Shanghai, China.
Xiaomeng MaoPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Hindu KalluruPfizer Healthcare India Private Limited, GPD Tamil Nadu, Chennai, India.
Candace BramsonPfizer Inc, Groton, CT, USA.
Steven G TerraPfizer Inc, Cambridge, MA, USA.
Jing LiuPfizer Inc, Groton, CT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVupanorsen is a GalNAc

objectivesThe aim of this study was to satisfy Chinese regulatory requirements and support ethnic sensitivity assessment by evaluating pharmacokinetics (PK), pharmacodynamics (PD), and safety of vupanorsen in healthy Chinese adults with elevated triglycerides (TG).

methodsIn this phase I, parallel-cohort, open-label study, 18 Chinese adults with elevated fasting TG (≥ 90 mg/dL) were randomized 1:1 to receive a single subcutaneous dose of vupanorsen 80 mg or 160 mg. PK parameters, PD markers (including ANGPTL3, TG, non-high-density lipoprotein cholesterol [non-HDL-C]), and safety were assessed.

resultsAbsorption of vupanorsen was rapid (median time to maximum concentration [T

conclusionsThis study provided the first clinical vupanorsen data in China. In Chinese participants with elevated TG, PK and PD parameters were consistent with those reported previously in non-Chinese participants, including in Japanese individuals. No safety concerns were noted.

trial registrationClinicalTrials.gov identifier: NCT04916795.

Indexed as

Angiopoietin-Like Protein 3Oligonucleotides, AntisenseTriglyceridesAdultAngiopoietin-like ProteinsChinaDose-Response Relationship, DrugEast Asian PeopleFemaleHumansHypertriglyceridemiaMaleMiddle AgedOligonucleotidesYoung AdultAngiopoietin-Like Protein 3Angiopoietin-like ProteinsANGPTL3 protein, humanOligonucleotidesOligonucleotides, AntisenseTriglycerides

Identifiers

PMID38949758
PMCPMC11315818

What Socratic holds

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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.