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

Official title

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

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.

Interventions

• Drug SHR-1918
  SHR-1918
• Drug SHR-1918 placebo
  SHR-1918 placebo

Primary outcome measures

• The percentage change of serum LDL-C from baseline; [Time frame: Baseline and Week 24]
• The percentage change in serum TG from baseline; [Time frame: Baseline and Week 24]

Secondary outcome measures (12)

• Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline; [Time frame: Baseline and Week 24]
• The percentage change in serum total cholesterol (TC) from baseline; [Time frame: Baseline and Week 24]
• The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24; [Time frame: Baseline and Week 24]
• The percentage change of serum apolipoprotein A1 (ApoA1) from baseline; [Time frame: Baseline and Week 24]
• The change from baseline in serum LDL-C； [Time frame: Baseline and Week 24]
• The change from baseline in serum TG； [Time frame: Baseline and Week 24]
• The change from baseline in serum non-HDL-C； [Time frame: Baseline and Week 24]
• The change from baseline in serum TC； [Time frame: Baseline and Week 24]
• The change from baseline in serum ApoB； [Time frame: Baseline and Week 24]
• The change from baseline in serum ApoA1； [Time frame: Baseline and Week 24]
• Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a)); [Time frame: Baseline and Week 24]
• Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C); [Time frame: Baseline and Week 24]

Eligibility criteria

Inclusion criteria

• 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；

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07230730 · SHR-1918-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗