RECRUITING Phase 3 ClinicalTrials.gov

A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd • ClinicalTrials.gov ID: NCT07230730

Registry updated: 2026-09-10

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Description

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.

Interventions

SHR-1918 (Drug)
SHR-1918
SHR-1918 placebo (Drug)
SHR-1918 placebo

Eligibility criteria

Inclusion Criteria: 1. the age must be at least 18 years old, and both men and women are eligible; 2. 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; 3. Fasting TG≥ 1.7 mmol/L; 4. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person. Exclusion Criteria: 1. poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization; 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) \> 3× upper limit of normal (ULN), or total bilirubin \> 2×ULN; 3. Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN； 4. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m\^2; 5. Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.

Conditions

Hyperlipidemia

Locations

The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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