NCT04885218

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

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 .

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	SHR-1209 ;placebo	SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks
DRUG	SHR-1209 ;placebo	SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks
DRUG	SHR-1209 ;placebo	SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2021-05-13
• Last updated: 2024-01-31

Locations

1 site across 1 country: China