Evidence map›Paper›PMID 39498965›Full record

Trial reportClinical and translational science2024

Clinical pharmacokinetics and pharmacodynamics of ongericimab: A potential long-acting PCSK9 monoclonal antibody in healthy subjects and patients with hypercholesterolemia: Randomized, double-blind, placebo-controlled phase Ia and Ib/II studies.

Juanjuan Jiang, Li Xu, Lin Chai, Xiaoyuan Guan, Li Zhang, Hong Liu, Yan Yan, Lili Li, Yi Zhao, Xuelian Bai and 2 more

Abstract readClinical Trial, Phase IRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 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. Trial
  4. Article
  5. Review
  6. Article
  7. Antibody-Based Therapeutics for Hypercholesterolemia.Biologics : targets & therapy · 2025
    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

12 authors.

Juanjuan JiangNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Li XuNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lin ChaiNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xiaoyuan GuanNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Li ZhangNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Hong LiuNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yan YanNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lili LiShanghai Junshi Biosciences, Shanghai, China.
Yi ZhaoShanghai Junshi Biosciences, Shanghai, China.
Xuelian BaiShanghai Junshi Biosciences, Shanghai, China.
Lei TianNHC Key Laboratory of Clinical Research for Cardiovascular Medications, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Youhong JiaDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Proprotein convertase subtilisin/kexin type 9 (PCSK9) increases plasma low-density lipoprotein-cholesterol (LDL-C) by decreasing the expression of the LDL-receptor on hepatic cells. Ongericimab (JS002) is a novel PCSK9 monoclonal antibody that exhibits a long-acting LDL-C lowering effect by exclusively inhibiting PCSK9 in pre-clinical studies. Two randomized, double-blind, placebo-controlled trials were conducted to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetic, and pharmacodynamic profiles of ongericimab in healthy subjects and patients with hypercholesterolemia. Eighty-four healthy subjects in the phase Ia study received a single dose of placebo or ongericimab (15-450 mg). Ninety patients with hypercholesterolemia in the phase Ib/II study received placebo or ongericimab 150 mg Q2W, 300 mg Q4W, or 450 mg Q4W for 12 weeks. Ongericimab exhibited non-linear kinetics. The apparent clearance decreased as the dosage increased, with terminal elimination half-life (t

Indexed as

Healthy VolunteersHypercholesterolemiaProprotein Convertase 9AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedPCSK9 InhibitorsTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID39498965
PMCPMC11536336

What OpenQuestion holds

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Registered trials

None linked

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.