HyperlipemiaPhase 1/2NCT04469673
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
A Phase 1/2 study testing Biological：JS002 in people with Hyperlipemia, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperlipemia
- What is being tested?
- Biological：JS002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2019to 28 Jun 2020
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥18 and ≤65 years old;
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
- Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
- Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
- Fasting triglycerides ≤4.5 mmol/L;
Who cannot join
- Diagnosis of homozygous familial hypercholesterolemia;
- History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
- History of uncontrolled arrhythmiast;
- History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
- History of stroke or TIA；
- Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
- Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
- Conditions
- Hyperlipemia
- Being tested
- Biological：JS002, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological：JS002Biological
Administered by subcutaneous injection
PlaceboBiological
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| JS002 | Experimental | Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses. Receives: Biological: Biological：JS002 |
| Placebo | Placebo comparator | Participants received matching placebo dose regimens by subcutaneous injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
Measured: 12 weeks after the first dose
Secondary outcomes (5)
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
Measured: Twelve weeks after the last dose
Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
Measured: Twelve weeks after the last dose
Percentage change from baseline TC/HDL-C ratio
Measured: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein B (Apo B)
Measured: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Measured: Twelve weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start23 May 2019
- Primary completion3 May 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
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
- NCT04469673
- Sponsor's protocol ID
- JS002-002
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.
- ClinicalTrials.gov ID
- NCT04469673
- Acronym / sponsor ID
- JS002-002
- Conditions
- Hyperlipemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 3 May 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 14 Jul 2020 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS002 | Experimental | Biological: Biological：JS002Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants received matching placebo dose regimens by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Age ≥18 and ≤65 years old;
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
- Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
- Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
Key exclusion criteria (7 listed)
- Diagnosis of homozygous familial hypercholesterolemia;
- History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
- History of uncontrolled arrhythmiast;
- History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
- History of stroke or TIA；
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 |
|---|---|---|
| Biological：JS002Administered by subcutaneous injection | Biological | JS002 |
| PlaceboAdministered by subcutaneous injection | Biological | Placebo |
Primary outcome
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
Time frame: 12 weeks after the first dose
5 secondary outcomes
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Twelve weeks after the last dose
Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
Time frame: Twelve weeks after the last dose
Percentage change from baseline TC/HDL-C ratio
Time frame: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein B (Apo B)
Time frame: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Time frame: Twelve weeks after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biological：JS002 in people with Hyperlipemia, 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 7 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 14 Jul 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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) to week 12 (time frame: 12 weeks after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020; AzTrials last refreshed its copy on 30 Oct 2026.