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

NCT04885218 | Completed Phase 3

• 1 other identifier: SHR-1209-302
• Study Type: interventional
• Target: 692
• Locations: 1 country
• Sites: 1

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

Conditions

Non-familial Hypercholesterolemia; Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change in LDL-C relative to baseline

  at 24 weeks of treatment

Secondary Outcomes (17)

• The value of change in LDL-C relative to baseline

  at 24 weeks of treatment

• Percentage change in LDL-C relative to baseline

  at 48 weeks of treatment;

• The value of change in LDL-C relative to baseline ,

  at 48 weeks of treatment;

• Percentage change in non-HDL-C relative to baseline

  at 24 weeks of treatment;

• Percentage change in non-HDL-C relative to baseline

  at 48 weeks of treatment;

Study Arms (3)

Cohort 1：SHR-1209 / placebo

EXPERIMENTAL

Drug: SHR-1209 ;placebo

Cohort 2：SHR-1209 /placebo

EXPERIMENTAL

Drug: SHR-1209 ;placebo

Cohort 3：SHR-1209 / placebo

EXPERIMENTAL

Drug: SHR-1209 ;placebo

Interventions

SHR-1209 ;placebo DRUG

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

Cohort 1：SHR-1209 / placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Fasting triglycerides less than equal to 5.6 mmol/L；
• Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

  PMID: 40587053 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1209 combined with lipid-lowering agents

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 13, 2021
• Study Start: July 30, 2021
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)