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NCT Number: NCT05532800

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

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.

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Key information

Conditions

Hyperlipemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anzhen Hospital，Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of NYHA class III-IV heart failure or EF<30%;
  • History of uncontrolled arrhythmia within 90 days;
  • History of MI,UA, PCI or CABG, stroke within 90 days;
  • Known hemorrhagic stroke disease;
  • Planned cardiac surgery or revascularization.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitius (HbA1c>8.0%）.
  • Other conditions that the researchers considered inappropriate to participate in the study.

Treatment and study plan

JS002

Drug

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

Placebo

Drug

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

Primary outcomes

  1. LDL-C with JS002 PFS

    Time frame: at week 12

    Percentage change in LDL-C relative to baseline at Week 12 with JS002 PFS

  2. LDL-C with JS002 AI

    Time frame: at week 12

    Percentage change in LDL-C relative to baseline at Week 12 with JS002 AI

Secondary outcomes

  1. LDL-C with JS002 PFS

    Time frame: at week 12

    The absolute change in LDL-C relative to baseline with JS002 PFS

  2. LDL-C with JS002 AI

    Time frame: at week 12

    The absolute change in LDL-C relative to baseline with JS002 AI

  3. lipid parameters

    Time frame: at week 12

    Percentages and absolute change in other lipid parameters to baseline with JS002 PFS and JS002 AI

  4. LDL-C reduction≥50 with JS002 PFS

    Time frame: at week 12

    Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 PFS from baseline

  5. LDL-C reduction≥50 with JS002 AI

    Time frame: at week 12

    Proportion of subjects with a ≥50% reduction in serum LDL-C at 12 weeks after subcutaneous treatment with JS002 AI from baseline

  6. LDL-C dropped to < 70 mg/dL with JS002 PFS

    Time frame: at week 12

    Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 PFS

  7. LDL-C dropped to < 70 mg/dL with JS002 AI

    Time frame: at week 12

    Proportion of subjects whose serum LDL-C dropped to < 70 mg/dL (1.8 mmol/L) at 12 weeks after subcutaneous injection of JS002 AI

  8. full dose

    Time frame: at week 0, 2, 4, 6, 8, 10

    Proportion of subjects receiving full dose of JS002 AI during treatment (weeks 0, 2, 4, 6, 8, 10)

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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