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Heterozygous Familial HypercholesterolemiaPhase 3NCT05325203

A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).

A Phase 3 study testing Ongericimab in people with Heterozygous Familial Hypercholesterolemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ongericimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
1 siteChina
Study dates
31 Dec 2021to 29 Jun 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Males and females ≥ 18 to ≤ 80 years of age
  • DLCN>8 in HeFH
  • Stable lipid-lowering therapies for at least 4 weeks
  • Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
  • Triglyceride≤4.5 mmol/L（400 mg/dL）;

Who cannot join

  • HoFH or meet the diagnostic criteria of HoFH
  • New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
  • History of uncontrolled arrhythmia within 90 days
  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
  • Planned cardiac surgery or revascularization.
  • Uncontrolled diabetes mellitius (HbA1c>8.0%）.
  • Uncontrolled hypertension.
  • Other conditions that the researchers considered inappropriate to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital Capital Medical University City:Beijing

    Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia

JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).

Read the detailed description

A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planned to be enrolled. Each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. To evaluate the lipid-lowering efficacy of subcutaneous injection of JS002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . Subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to JS002 150 mg Q2W or JS002 450 mg Q4W or matched placebo to receive the study drug (JS002) or placebo subcutaneously for 24 weeks.

treatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W

Being tested
Ongericimab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OngericimabBiological

    Also called JS002

    Administered by subcutaneous injection

  • PlaceboDrug

    Administered by subcutaneous injection

Study groups in NCT05325203
Study groupRoleWhat they receive
JS002 150mg Q2W for 24 weeksExperimental40 patients will be enrolled in this arm
Receives: Biological: Ongericimab
placebo 150mg Q2W for 24 weeksPlacebo comparator20 patients will be enrolled in this arm
Receives: Drug: Placebo
JS002 450mg Q4W for 24 weeksExperimental40 patients will be enrolled in this arm
Receives: Biological: Ongericimab
placebo 450mg Q4W for 24 weeksPlacebo comparator20 patients will be enrolled in this arm
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

    LDL-C was quantified using the enzymatic colorimetric assay

    Measured: Baseline and week 24

Secondary outcomes (18)

  1. Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

    LDL-C was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  2. Percentage changes From Baseline in the Total Cholesterol at week 24

    TC was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  3. Absolute changes From Baseline in the Total Cholesterol at week 24

    TC was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  4. Percentage changes From Baseline in Non-HDL-C at Week 24

    Non-HDL-C was quantified using the Calculation,TC minus HDL-C

    Measured: Baseline and Week 24

  5. Absolute changes From Baseline in Non-HDL-C at Week 24

    Non-HDL-C was quantified using the Calculation,TC minus HDL-C

    Measured: Baseline and Week 24

  6. Percentage changes From Baseline in Apo B at Week 24

    Apo B was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  7. Absolute changes From Baseline in Apo B at Week 24

    Apo B was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  8. Percentage changes From Baseline in Lp(a) at Week 24

    Lp(a) was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  9. Absolute changes From Baseline in Lp(a) at Week 24

    Lp(a) was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  10. Percentage changes From Baseline in HDL-C at Week 24

    HDL-C was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  11. Absolute changes From Baseline in HDL-C at Week 24

    HDL-C was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  12. Percentage changes From Baseline in Apo A1 at Week 24

    Apo A1 was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  13. Absolute changes From Baseline in Apo A1 at Week 24

    Apo A1 was quantified using the turbidimetric immunoassay(TIA)

    Measured: Baseline and Week 24

  14. Percentage changes From Baseline in TG at Week 24

    TG was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  15. Absolute changes From Baseline in TG at Week 24

    TG was quantified using the enzymatic colorimetric assay

    Measured: Baseline and Week 24

  16. The ratio of TC/HDL - C

    Calculation

    Measured: Baseline and Week 24

  17. The ratio of Apo B/Apo A1

    Calculation

    Measured: Baseline and Week 24

  18. Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24

    Calculation

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start31 Dec 2021
  3. Primary completion8 May 2023
  4. Study completion29 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325203
Sponsor's protocol ID
JS002-005
Status last verified
Feb 2022
First submitted
8 Feb 2022
Last updated
18 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin J, Ji Y, Wang G, Ma X, Yao Z, Han X, Chen J, Chen J, Huang W, Xu G, Peng D, Yan P, Qiao P, He Y, Tang Y, Wang M, Zhang M, Yu J, Hao Y, Ma C. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Apr;403:119120. doi: 10.1016/j.atherosclerosis.2025.119120. Epub 2025 Jan 29.

    PubMed 39999660

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ongericimab in people with Heterozygous Familial Hypercholesterolemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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