Trial reportJournal of the American Heart Association2024

Efficacy and Safety of Ongericimab in Chinese Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.

Xiaozeng Wang, Miaohan Qiu, Zhifeng Cheng, Xianyou Ji, Jiyan Chen, Hong Zhu, Yida Tang, Zhouqing Huang, Guohai Su, Gaopin Wang and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of the American Heart Association, 2024. The graph read 1 number from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. It is linked to trial NCT04781114 (A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

1number the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
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.

Read, but not usablea number the graph found but could not read as for or against

Lipidscomparator not stated · dyslipidemiafeeds one cell of the map
Δ -67.7-72.5 to -63.0
Our findings demonstrated that the least-squares mean difference of percentage change in LDL-C from baseline to week 24 was -67.7% (95% CI, -72.5% to -63.0%; CONCLUSIONS: Ongericimab, as an add-on treatment to optimized lipid-lowering therapy, significantly reduced LDL-C and was well-tolerated in Chinese patients with primary hyperlipidemia and mixed dyslipidemia who did not achieve their LDL-C targets.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

PCSK9 inhibitors×lipids

No readable resultOpen on the map →What to test next →

34 readable studies in this cell: 30 favour the treatment, 1 find no difference, 3 favour the comparator.

Belief with this paper
0.93established · 26 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017638662,067 enrolled · 2013
Δ -71.4-77.5 to -65.3
NCT034008001,617 enrolled · 2017
Δ -53.5-56.7 to -50.4
NCT02662569986 enrolled · 2016
Δ -70.3-75.4 to -65.2
NCT04807400892 enrolled · 2021
Least Squares Mean -31.8-37.9 to -25.8
NCT01380730631 enrolled · 2011
Δ -66.1-71.5 to -60.7
NCT01763827615 enrolled · 2013
Δ -57.1-61.1 to -53.1
NCT01984424511 enrolled · 2013
Δ -37.8-42.3 to -33.3
NCT02833844467 enrolled · 2017
Δ -56.9-61.5 to -52.3
NCT04929249450 enrolled · 2021
Δ -53.0-60.0 to -46.0
NCT02739984424 enrolled · 2016
Δ -64.1-68.2 to -60.1
NCT02642159413 enrolled · 2016
Δ -32.5-38.1 to -27.0
NCT01375777411 enrolled · 2011
Δ -47.2-54.5 to -39.9

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

NCT04781114 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia in China

TypeinterventionalSponsorShanghai Junshi Bioscience Co., Ltd.Ran2020 to 2023Enrolled806ConditionsHyperlipemiaArmsJS002, Placebo
5 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Efficacy and Safety of Ongericimab in Chinese Patients with Hypercholesterolemia: A Meta-analysis of Randomized Controlled Trials.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025
    Review
  6. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

19 authors.

Xiaozeng WangGeneral Hospital of Northern Theater Command Shenyang China.ORCID 0000-0003-1979-0287
Miaohan QiuGeneral Hospital of Northern Theater Command Shenyang China.
Zhifeng ChengThe Fourth Hospital of Harbin Medical University Harbin China.
Xianyou JiDaqing People's Hospital Daqing China.
Jiyan ChenGuangdong General Hospital Guangzhou China.ORCID 0000-0003-1216-9316
Hong ZhuThe Affiliated Hospital of Xuzhou Medical University Xuzhou China.
Yida TangPeking University Third Hospital Beijing China.
Zhouqing HuangThe First Affiliated Hospital of Wenzhou Medical University Wenzhou China.ORCID 0000-0001-5854-1377
Guohai SuJinan Central Hospital Jinan China.
Gaopin WangThe First Affiliated Hospital of Jinzhou Medical University Jinzhou China.
Zhijun HuangThe Third Xiangya Hospital of Central South University Changsha China.ORCID 0000-0003-1539-5212
Zhuhua YaoTianjin People's Hospital Tianjin China.
Jinxiu LinThe First Affiliated Hospital of Fujian Medical University Fuzhou China.
Yihong SunChina-Japan Friendship Hospital Beijing China.ORCID 0000-0001-7812-9793
Shunhui LiThe First Hospital of Nanchang Nanchang China.
Cong ShaoShanghai Junshi Biosciences Co., Ltd. Shanghai China.
Yi ZhaoShanghai Junshi Biosciences Co., Ltd. Shanghai China.ORCID 0009-0000-8514-0843
Xuelian BaiShanghai Junshi Biosciences Co., Ltd. Shanghai China.ORCID 0000-0002-6989-6699
Yaling HanGeneral Hospital of Northern Theater Command Shenyang China.ORCID 0000-0003-2453-6443

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundA phase 3 trial was conducted to evaluate the efficacy and safety of ongericimab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, as an add-on treatment to optimized lipid-lowering therapy in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia. METHODS AND

resultsA total of 806 patients who were receiving stable and optimized lipid-lowering therapy but did not achieve their low-density lipoprotein cholesterol (LDL-C) targets were enrolled and randomly assigned in a 2:1:2:1 ratio to receive either ongericimab 150 mg or matching placebo every 2 weeks, or ongericimab 300 mg or matching placebo every 4 weeks for 52 weeks. Efficacy and safety were evaluated in 802 patients who received at least 1 dose of ongericimab or placebo. The primary end point was the percentage change in LDL-C from baseline to week 24. Our findings demonstrated that the least-squares mean difference of percentage change in LDL-C from baseline to week 24 was -67.7% (95% CI, -72.5% to -63.0%;

conclusionsOngericimab, as an add-on treatment to optimized lipid-lowering therapy, significantly reduced LDL-C and was well-tolerated in Chinese patients with primary hyperlipidemia and mixed dyslipidemia who did not achieve their LDL-C targets. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04781114.

Indexed as

Cholesterol, LDLDyslipidemiasHypercholesterolemiaPCSK9 InhibitorsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersChinaDouble-Blind MethodDrug Therapy, CombinationEast Asian PeopleFemaleHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersCholesterol, LDLPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9hypercholesterolemialipid‐lowering therapylow‐density lipoprotein cholesterolmixed dyslipidemiaPCSK9

Identifiers

PMID38818934
PMCPMC11255649

What Socratic holds

Texttitle and abstract
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.