Overview

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

Status:
Recruiting

Trial end date:
2023-02-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shanghai Junshi Bioscience Co., Ltd.

Criteria

A limited list of criteria for selection of participants in the clinical study, provided in
terms of inclusion and exclusion criteria and suitable for assisting potential participants
in identifying clinical studies of interest. Use a bulleted list for each criterion below
the headers "Inclusion Criteria" and "Exclusion Criteria". (Limit: 15,000 characters.)

Inclusion Criteria:

1. Signed informed consent.

2. Age 18~80 years old;

3. Stable optimized LLT at least 4 weeks before randomization;

4. At the time of screening, Low-density lipoprotein cholesterol (LDL-C) level according
to ASCVD risks:

- extra high risk patients: LDL-C≥1.4mmol/L(55mg/dL)

- very high risk patients: LDL-C≥1.8mmol/L(70mg/dL)

- high risk patients: LDL-C≥2.6mmol/L(100mg/dL)

- moderate and low risk patients: LDL-C≥3.4mmol/L(130mg/dL)

4.Fasting triglycerides ≤4.5 mmol/L(400mg/dL);

Exclusion Criteria:

1. History of NYHA class III-IV heart failure or EF<30%

2. History of uncontrolled arrhythmia within 3 months

3. History of MI,UA, PCI or CABG, stroke within 3 months.

4. History of DVT or pulmonary embolism within 3 months.

5. Planned cardiac surgery or revascularization.

6. Uncontrolled hypertension.

7. Uncontrolled diabetes mellitius (HbA1c>8.0%）.

8. Other conditions that the researchers considered inappropriate to participate in the
study.