Clinical trial NCT04469673: A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperlipemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.


Eligibility criteria: 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%);

Primary outcomes:
measure: Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
timeFrame: 12 weeks after the first dose
Secondary outcomes:
measure: Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Twelve weeks after the last dose
measure: Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )
timeFrame: Twelve weeks after the last dose
measure: Percentage change from baseline TC/HDL-C ratio
timeFrame: Twelve weeks after the last dose
measure: Percent change from baseline in Apolipoprotein B (Apo B)
timeFrame: Twelve weeks after the last dose
measure: Percent change from baseline in Apolipoprotein A-I (ApoA-I)
timeFrame: Twelve weeks after the last dose
Other outcomes:
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
timeFrame: Twelve weeks after the last dose
measure: Serum concentrations of JS002
timeFrame: Twelve weeks after the last dose
measure: Change from baseline in proprotein convertase total / free pcsk9
timeFrame: Twelve weeks after the last dose
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences
Study officials:
References: