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Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia

NCT04885218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2024-01-31

No results posted yet for this study

Summary

To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy

Conditions

  • Non-familial Hypercholesterolemia
  • Mixed Hyperlipidemia

Interventions

DRUG

SHR-1209 ;placebo

SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks

DRUG

SHR-1209 ;placebo

SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks

DRUG

SHR-1209 ;placebo

SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2023-05-23
Completion
2023-05-23

Countries

  • China

Study Locations

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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 NCT04885218 on ClinicalTrials.gov