A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

Phase 1

Completed

• Conditions: Hyperlipemia
• Interventions: Biological: Biological：JS002; Biological: Placebo

• Registration Number: NCT04469673
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Brief Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Primary Completion: 2020-05-03
• Study Completion: 2020-06-28
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-14
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Signed informed consent.
2. Age ≥18 and ≤65 years old;
3. Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
4. 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;
5. 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;
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria

1. Diagnosis of homozygous familial hypercholesterolemia;
2. History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
3. History of uncontrolled arrhythmiast;
4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
5. History of stroke or TIA；
6. Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JS002	Biological：JS002	Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
Placebo	Placebo	Participants received matching placebo dose regimens by subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12	12 weeks after the first dose

Secondary Outcome Measures

Name	Time	Method
Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)	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 )	Twelve weeks after the last dose
Percentage change from baseline TC/HDL-C ratio	Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein B (Apo B)	Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein A-I (ApoA-I)	Twelve weeks after the last dose

Trial Locations

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China