The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Shanghai Junshi Biosciences

Status and phase: Completed; Phase 3

Conditions: Hyperlipemia

Treatments: Drug: Placebo; Drug: JS002

Study type: Interventional

Funder types: Other

Identifiers

NCT05532800

JS002-006

Details and patient eligibility

About

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed hyperlipidemia when combined with statin therapy.

In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002 AI / placebo ).

Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks of follow-up.

Enrollment: 255 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent.
2. Age 18~80 years old;
3. Stable optimized LLT at least 4 weeks before randomization;
4. Two times of Fasting triglycerides ≤4.5 mmol/L(400mg/dL)at the time of screening;

Exclusion criteria

1. History of NYHA class III-IV heart failure or EF<30%;
2. History of uncontrolled arrhythmia within 90 days;
3. History of MI,UA, PCI or CABG, stroke within 90 days;
4. Known hemorrhagic stroke disease;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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255 participants in 2 patient groups, including a placebo group

JS002

Experimental group

Description:

Cobort 1:150 mg/1mL Q2W PFS,Cobort 2:150 mg/1mL Q2W AI

Treatment:

Drug: JS002

Placebo

Placebo Comparator group

Description:

Cobort 1:/1mL Q2W PFS,Cobort 2:1mL Q2W AI

Treatment:

Drug: Placebo