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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

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 criteria

Qualifiers

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≥ 1.7 mmol/L;

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR-1918
  • SHR-1918 placebo

Treatment groups

900 Participants
are divided into 4 treatment groups