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

Study Overview
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Brief Summary
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To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with hypercholesterolemia and hyperlipidemia after lipid-lowering therapy

Official Title
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A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in the Stable Treatment of Patients With Hypercholesterolemia and Hyperlipidemia .

Conditions
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Hypercholesterolemia, Hyperlipidemia

Intervention / Treatment
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* Drug: SHR-1209 ;placebo
* Drug: SHR-1209 ;placebo
* Drug: SHR-1209 ;placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤80 on the date of signing the informed consent, male or female; The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history; Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. Exclusion Criteria: 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 ; 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); 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR-1209 combined with lipid-lowering agents
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1：SHR-1209 / placebo<br> | Drug: SHR-1209 ;placebo<br>* SHR-1209/placebo high dose<br>|
| Experimental: Cohort 2：SHR-1209 /placebo<br> | Drug: SHR-1209 ;placebo<br>* SHR-1209/placebo medium dose<br>|
| Experimental: Cohort 3：SHR-1209 / placebo<br> | Drug: SHR-1209 ;placebo<br>* SHR-1209/placebo low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in LDL-C relative to baseline |  | at 24 weeks of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of changes in LDL-C relative to baseline |  | at 24 weeks of treatment. | 
| blood pressure with the unit of mm Hg |  | through study completion, an average of 56 weeks | 
| body temperature with the unit of °C |  | through study completion, an average of 56 weeks | 
| pulse rate with the unit of beats per minute |  | through study completion, an average of 56 weeks | 
| Breathe with the unit of beats per minunt |  | through study completion, an average of 56 weeks | 
| adverse events |  | through study completion, an average of 56 weeks | 
| injection reactions, the investigators through check up the skin of abdomen |  | through study completion, an average of 56 weeks |