Clinical trial NCT04885218: Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia
Official title: 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 Non-familial Hypercholesterolemia and Mixed Hyperlipidemia .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-familial Hypercholesterolemia
Mixed Hyperlipidemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 692
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1209 combined with lipid-lowering agents
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage change in LDL-C relative to baseline
timeFrame: at 24 weeks of treatment
Secondary outcomes:
measure: The value of change in LDL-C relative to baseline
timeFrame: at 24 weeks of treatment
measure: Percentage change in LDL-C relative to baseline
timeFrame: at 48 weeks of treatment;
measure: The value of change in LDL-C relative to baseline ,
timeFrame: at 48 weeks of treatment;
measure: Percentage change in non-HDL-C relative to baseline
timeFrame: at 24 weeks of treatment;
measure: Percentage change in non-HDL-C relative to baseline
timeFrame: at 48 weeks of treatment;
measure: Percentage change in ApoB relative to baseline
timeFrame: at 24 weeks of treatment;
measure: Percentage change in ApoB relative to baseline
timeFrame: at 48 weeks of treatment;
measure: Percentage change in TC/HDL-C relative to baseline
timeFrame: at 24 weeks of treatment;
measure: Percentage change in TC/HDL-C relative to baseline,
timeFrame: at 48 weeks of treatment
measure: Percentage change in ApoB/ApoA1 relative to baseline,
timeFrame: at 24 weeks of treatment;
measure: Percentage change in ApoB/ApoA1 relative to baseline,
timeFrame: at 48 weeks of treatment;
measure: Percentage change in LP (a) relative to baseline,
timeFrame: at 24 weeks of treatment;
measure: Percentage change in LP (a) relative to baseline,
timeFrame: at 48 weeks of treatment;
measure: Percentage change in TG relative to baseline
timeFrame: at 24 weeks of treatment
measure: Percentage change in TG relative to baseline
timeFrame: at 48 weeks of treatment;
measure: Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
timeFrame: at 48 weeks of treatment;
measure: Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,
timeFrame: at 48 weeks of treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen hospital
state: Beijing
Study officials:
References: