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Completed

NCT Number: NCT04469673

A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

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 and ≤65 years old;
  • Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
  • Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
  • Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
  • Fasting triglycerides ≤4.5 mmol/L;

Exclusion criteria

  • Diagnosis of homozygous familial hypercholesterolemia;
  • History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
  • History of uncontrolled arrhythmiast;
  • History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
  • History of stroke or TIA;
  • Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
  • Type 1 diabetes, or type 2 diabetes that is or poorly controlled(HbA1c> 8.0%);

Treatment and study plan

Biological:JS002

Biological

Administered by subcutaneous injection

Placebo

Biological

Administered by subcutaneous injection

Primary outcomes

  1. Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12

    Time frame: 12 weeks after the first dose

Secondary outcomes

  1. Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Twelve weeks after the last dose

  2. Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG )

    Time frame: Twelve weeks after the last dose

  3. Percentage change from baseline TC/HDL-C ratio

    Time frame: Twelve weeks after the last dose

  4. Percent change from baseline in Apolipoprotein B (Apo B)

    Time frame: Twelve weeks after the last dose

  5. Percent change from baseline in Apolipoprotein A-I (ApoA-I)

    Time frame: Twelve weeks after the last dose

Other outcomes

  1. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    Time frame: Twelve weeks after the last dose

  2. Serum concentrations of JS002

    Time frame: Twelve weeks after the last dose

  3. Change from baseline in proprotein convertase total / free pcsk9

    Time frame: Twelve weeks after the last dose

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Jul 14, 2020

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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