Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Hypercholesterolaemia and Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JS002 150mg Q2W

JS002 150mg Q2W SC for 52 weeks

Group Type EXPERIMENTAL

JS002

Intervention Type DRUG

JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.

JS002 450mg Q4W

JS002 450mg Q4W SC for 52 weeks

Group Type PLACEBO_COMPARATOR

JS002

Intervention Type DRUG

JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.

Placebo Q2W

Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.

Placebo Q4W

Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.

Interventions

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JS002

JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.

Intervention Type DRUG

JS002

JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.

Intervention Type DRUG

Placebo

Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.

Intervention Type DRUG

Placebo

Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent
2. Age 18\~80 years old
3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening
4. Fasting TG≤4.5mmol/L by central laboratory at screening
5. Statin intolerance subject must have a history of statin intolerance as evidenced

Exclusion Criteria

1. History of hemorrhagic stroke
2. NYHA III or IV heart failure, or known LVEF\< 30% within 1 year before randomization
3. 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
4. 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
5. Planned cardiac surgery or revascularization
6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \> 160 mmHg or diastolic BP (DBP) \> 100 mmHg
7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)
8. Others factors not suitable for participation judged by PI

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No