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

Hyperlipemia Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes(PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05532800
Study type	Interventional
Source	Shanghai Junshi Bioscience Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	February 28, 2022
Completion date	February 9, 2023

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