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

Shanghai Junshi Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hyperlipemia

Treatments: Biological: Biological：JS002; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04469673

JS002-002

Details and patient eligibility

About

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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%);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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90 participants in 2 patient groups, including a placebo group

JS002

Experimental group

Description:

Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.

Treatment:

Biological: Biological：JS002

Placebo

Placebo Comparator group

Description:

Participants received matching placebo dose regimens by subcutaneous injection.

Treatment:

Biological: Placebo