A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• the age must be at least 18 years old, and both men and women are eligible;

• the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;

• Fasting TG≥2.3,and ≤5.6 mmol/L;

• Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person;

Locations
Other Locations
China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Sheng Qi
Sheng.qi@hengrui.com
+86 0518 82342973
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2027-10
Participants
Target number of participants: 900
Treatments
Experimental: SHR-1918 low dose
Placebo_comparator: SHR-1918 placebo low dose
Experimental: SHR-1918 high dose
Placebo_comparator: SHR-1918 placebo high dose
Related Therapeutic Areas
Sponsors
Leads: Beijing Suncadia Pharmaceuticals Co., Ltd

This content was sourced from clinicaltrials.gov