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

Mixed Hyperlipidemia Clinical Trial

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885218
• Other study ID #: SHR-1209-302
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: January 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Hyperlipoproteinemias
• Mixed Hyperlipidemia
• Non-familial Hypercholesterolemia

Intervention

Drug:
• SHR-1209 ;placebo
SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks
• SHR-1209 ;placebo
SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks
• SHR-1209 ;placebo
SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks

Locations

Country	Name	City	State
China	Beijing Anzhen hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in LDL-C relative to baseline		at 24 weeks of treatment
Secondary	The value of change in LDL-C relative to baseline		at 24 weeks of treatment
Secondary	Percentage change in LDL-C relative to baseline		at 48 weeks of treatment;
Secondary	The value of change in LDL-C relative to baseline ,		at 48 weeks of treatment;
Secondary	Percentage change in non-HDL-C relative to baseline		at 24 weeks of treatment;
Secondary	Percentage change in non-HDL-C relative to baseline		at 48 weeks of treatment;
Secondary	Percentage change in ApoB relative to baseline		at 24 weeks of treatment;
Secondary	Percentage change in ApoB relative to baseline		at 48 weeks of treatment;
Secondary	Percentage change in TC/HDL-C relative to baseline		at 24 weeks of treatment;
Secondary	Percentage change in TC/HDL-C relative to baseline,		at 48 weeks of treatment
Secondary	Percentage change in ApoB/ApoA1 relative to baseline,		at 24 weeks of treatment;
Secondary	Percentage change in ApoB/ApoA1 relative to baseline,		at 48 weeks of treatment;
Secondary	Percentage change in LP (a) relative to baseline,		at 24 weeks of treatment;
Secondary	Percentage change in LP (a) relative to baseline,		at 48 weeks of treatment;
Secondary	Percentage change in TG relative to baseline		at 24 weeks of treatment
Secondary	Percentage change in TG relative to baseline		at 48 weeks of treatment;
Secondary	Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,		at 48 weeks of treatment;
Secondary	Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,		at 48 weeks of treatment.