SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

Study Overview
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Brief Summary
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This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.

Official Title
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A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia

Conditions
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Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: SHR-1209
* Drug: SHR-1209 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any male or female aged between 18 and 80 on the date of signing the informed consent; Diagnosed as hypercholesterolemia ; Fasting triglyceride was less than 5.6 mmol/L during screening: Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. Exclusion Criteria: A history of the following diseases or treatments during the screening period: Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past; Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer); Any of the laboratory test indicators meets the following criteria: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random; The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random; Have used the following drugs: PCSK9 inhibitors had been used in the previous 6 months; Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened. Other circumstances: Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.

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: Background Lipolowering therapy in combination with SHR-1209/ placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1209<br> | Drug: SHR-1209<br>* SHR-1209<br>|
| Placebo Comparator: SHR-1209 Placebo<br> | Drug: SHR-1209 Placebo<br>* SHR-1209 Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 weeks Percentage change in serum LDL-C levels from baseline. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 weeks Absolute Changes in serum LDL-C levels from baseline； |  | 12 weeks | 
| 12 weeks Percentage change of non-HDL-C relative to baseline； |  | 12 weeks |