A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
Beijing Suncadia Pharmaceuticals Co., Ltd
900 participants
Jan 13, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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；
Exclusion Criteria5
- poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \> 3× upper limit of normal (ULN), or total bilirubin \> 2×ULN；
- Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
- The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2；
- Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc
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Interventions
SHR-1918
SHR-1918 placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07230730