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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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 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≥2.3,and ≤5.6 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/1.73m2;
  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

Study details
    Hyperlipidemia

NCT07230730

Beijing Suncadia Pharmaceuticals Co., Ltd

26 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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