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The Safety and Efficacy of Mu...

The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia

Last Updated: 2023-04-19

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2023-01-16

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 safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy.

In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo).

Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

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Detailed Description

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Conditions

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Hyperlipemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JS002

Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC);

Group Type EXPERIMENTAL

JS002

Intervention Type DRUG

JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.

Placebo

Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Interventions

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JS002

JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.

Intervention Type DRUG

Placebo

JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females ≥ 18 and ≤ 80 years of age;
2. LDL\_C during screening period met the following conditions: super high risk: LDL - C ≥1.4mmol/L (55 mg/dL); extremely high risk: LDL - C ≥1.8 mmol/L (70 mg/dL); risk: LDL - C ≥2.6 mmol/L (100 mg/dL); low risk: LDL - C ≥ 3.4 /mmol/L (130 mg/dL)
3. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria

1. Known HoFH;
2. History of NYHA class III-IV heart failure;
3. History of uncontrolled arrhythmia, Unstable angina,MI, PCI,CABG, DVT or pulmonary embolism within 3 months.
4. Uncontrolled hypertension.
5. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
6. Other conditions that investigators considered inappropriate to participate in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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