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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-05-23

Brief Summary

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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

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Detailed Description

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Conditions

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Non-familial Hypercholesterolemia Mixed Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-1209 combined with lipid-lowering agents

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1：SHR-1209 / placebo

Group Type EXPERIMENTAL

SHR-1209 ;placebo

Intervention Type DRUG

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

Cohort 2：SHR-1209 /placebo

Group Type EXPERIMENTAL

SHR-1209 ;placebo

Intervention Type DRUG

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

Cohort 3：SHR-1209 / placebo

Group Type EXPERIMENTAL

SHR-1209 ;placebo

Intervention Type DRUG

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

Interventions

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SHR-1209 ;placebo

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

Intervention Type DRUG

SHR-1209 ;placebo

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

Intervention Type DRUG

SHR-1209 ;placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
2. The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;
3. Fasting triglycerides less than equal to 5.6 mmol/L；
4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria

1. Have the following diseases or treatment history : (1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF\<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.
2. Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
3. General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening; Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
4. The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No