CompletedNCT04469673Updated Jul 14, 2020

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

A Phase 1/2 interventional study of Biological：JS002 and Placebo in Hyperlipemia, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled May 2019, registered Jul 2020).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Conditions studied

Hyperlipemia

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Hyperlipidemias 821

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 90 is close to the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

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Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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%);

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 90 participants (actual)

Study arms

Experimental
JS002
Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.
Biological: Biological：JS002
Placebo comparator
Placebo
Participants received matching placebo dose regimens by subcutaneous injection.
Biological: Placebo

Interventions

BiologicalBiological：JS002
Administered by subcutaneous injection
BiologicalPlacebo
Administered by subcutaneous injection

What researchers measure

Primary outcomes

Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12
Time frame: 12 weeks after the first dose

Secondary outcomes

Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Twelve weeks after the last dose
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
Percentage change from baseline TC/HDL-C ratio
Time frame: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein B (Apo B)
Time frame: Twelve weeks after the last dose
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Time frame: Twelve weeks after the last dose

Other outcomes

Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: Twelve weeks after the last dose
Serum concentrations of JS002
Time frame: Twelve weeks after the last dose
Change from baseline in proprotein convertase total / free pcsk9
Time frame: Twelve weeks after the last dose

Study locations

1 site

Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04469673
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Responsible party: Sponsor
First posted: Jul 14, 2020
Start date: May 23, 2019
Primary completion: May 3, 2020
Completion: Jun 28, 2020
Last update: Jul 14, 2020

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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