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

NCT05532800 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2023-03-15

No results posted yet for this study

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.

Conditions

  • Hyperlipemia

Interventions

DRUG

JS002

JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.

DRUG

Placebo

JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-02-09
Completion
2023-02-09

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532800 on ClinicalTrials.gov