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

Last updated: March 14, 2023
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Completed

Phase

3

Condition

High Cholesterol (Hyperlipidemia)

Elevated Triglycerides (Hypertriglyceridemia)

Familial Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT05532800
JS002-006
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 thestudy.

Study Design

Total Participants: 255
Study Start date:
February 28, 2022
Estimated Completion Date:
February 09, 2023

Connect with a study center

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing, Beijing 100029
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100192
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Daqing People's Hospital

    Daqing, Heilongjiang 163711
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434020
    China

    Site Not Available

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu 213004
    China

    Site Not Available

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221004
    China

    Site Not Available

  • Nanchang First Hospital

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • Nanchang Third Hospital

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130061
    China

    Site Not Available

  • Dalian Municipal Central Hospital

    Dalian, Liaoning 116089
    China

    Site Not Available

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning 121011
    China

    Site Not Available

  • Xianyang Hospital of Yan'an University

    Xianyang, Shanxi 716099
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, Tianjin 300122
    China

    Site Not Available

  • Taizhou Hospital Of Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325015
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.