Primary Hypercholesterolaemia and Mixed DyslipidemiaPhase 3NCT05621070
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
A Phase 3 study testing JS002 in people with Primary Hypercholesterolaemia and Mixed Dyslipidemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypercholesterolaemia and Mixed Dyslipidemia
- What is being tested?
- JS002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2023to 30 Sep 2024
- 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
- Age 18~80 years old
- Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
- Fasting TG≤4.5mmol/L by central laboratory at screening
- Statin intolerance subject must have a history of statin intolerance as evidenced
Who cannot join
- History of hemorrhagic stroke
- NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
- Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
- Planned cardiac surgery or revascularization
- Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
- Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
- Others factors not suitable for participation judged by PI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yida Tang, Doctor
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
- Being tested
- JS002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS002Drug
JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.
JS002Drug
JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.
PlaceboDrug
Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.
PlaceboDrug
Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| JS002 150mg Q2W | Experimental | JS002 150mg Q2W SC for 52 weeks Receives: Drug: JS002 |
| JS002 450mg Q4W | Placebo comparator | JS002 450mg Q4W SC for 52 weeks Receives: Drug: JS002 |
| Placebo Q2W | Placebo comparator | Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks Receives: Drug: Placebo |
| Placebo Q4W | Placebo comparator | Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Measured: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
Measured: Baseline and week 12
Secondary outcomes (6)
Change From Baseline in LDL-C at Week 12
Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects
Measured: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 24,52
Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Measured: Baseline and week 24,52
Change From Baseline in LDL-C at Week 24,52
Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects
Measured: Baseline and week 24,52
Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects
Measured: Baseline and week 12, 24, 52
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL) at Week 12, 24, 52 in statin intolerance and ITT subjects
Measured: Baseline and week 12, 24, 52
Percentage of Participants With Full Administration of JS002
Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects
Measured: Baseline and week 12, 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start3 Feb 2023
- Primary completion23 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Hypercholesterolaemia and Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621070
- Sponsor's protocol ID
- JS002-007
- Status last verified
- Sep 2024
- First submitted
- 14 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shao C, Zhang S, Cheng Z, Yang K, Wang G, Shi X, Yang H, Ji Y, Li H, Zhang S, Ma J, Pei Z, Zhang Y, Li Y, Li L, Zheng Y, Shao C, Zhang M, Hao Y, Tang YD. Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Aug;407:120408. doi: 10.1016/j.atherosclerosis.2025.120408. Epub 2025 Jun 16.
PubMed 40543299
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT05621070
- Acronym / sponsor ID
- JS002-007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 23 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.
In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JS002 150mg Q2W | Experimental | Drug: JS002JS002 150mg Q2W SC for 52 weeks |
| JS002 450mg Q4W | Placebo comparator | Drug: JS002JS002 450mg Q4W SC for 52 weeks |
| Placebo Q2W | Placebo comparator | Drug: PlaceboPlacebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks |
| Placebo Q4W | Placebo comparator | Drug: PlaceboPlacebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age 18~80 years old
- Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
- Fasting TG≤4.5mmol/L by central laboratory at screening
- Statin intolerance subject must have a history of statin intolerance as evidenced
Key exclusion criteria (8 listed)
- History of hemorrhagic stroke
- NYHA III or IV heart failure, or known LVEF< 30% within 1 year before randomization
- Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization
- Planned cardiac surgery or revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS002JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously. | Drug | JS002 150mg Q2W |
| JS002JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously. | Drug | JS002 450mg Q4W |
| PlaceboPlacebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously. | Drug | Placebo Q2W |
| PlaceboPlacebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously. | Drug | Placebo Q4W |
Primary outcome
Percent Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects
Percent Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 12 in ITT subjects
6 secondary outcomes
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in LDL-C at Week 24,52
Time frame: Baseline and week 24,52
Change From Baseline in LDL-C at Week 24,52
Time frame: Baseline and week 24,52
Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52
Time frame: Baseline and week 12, 24, 52
Percentage of Participants With LDL-C Less Than 1.8 mmol/L(70 mg/dL)
Time frame: Baseline and week 12, 24, 52
Percentage of Participants With Full Administration of JS002
Time frame: Baseline and week 12, 24, 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40543299Shao C, Zhang S, Cheng Z, Yang K, Wang G, Shi X, Yang H, Ji Y, Li H, Zhang S, Ma J, Pei Z, Zhang Y, Li Y, Li L, Zheng Y, Shao C, Zhang M, Hao Y, Tang YD. Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Aug;407:120408. doi: 10.1016/j.atherosclerosis.2025.120408. Epub 2025 Jun 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JS002 in people with Primary Hypercholesterolaemia and Mixed Dyslipidemia, 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 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiu'e Wan, PM (86 17710342522, qiu.e_wan@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LDL-C at Week 12 (time frame: Baseline and week 12). The study lists 2 primary outcomes in all. 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 NCT05621070, 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 19 Sep 2024.