SHR-1918 to lower LDL cholesterol and triglycerides in adults with hyperlipidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized, placebo-controlled trial compares SHR-1918 with matching placebo in adults with hyperlipidemia on stable statin therapy. Eligible participants meet LDL-C thresholds based on ASCVD risk category and have fasting triglycerides between 2.3 and 5.6 mmol/L; they receive study drug or placebo and undergo regular lipid measurements. Safety monitoring includes liver enzymes and thyroid function, and participants with poorly controlled hypertension or significant liver enzyme elevations are excluded. The trial is being conducted at The Second Affiliated Hospital Zhejiang University School of Medicine in Hangzhou and requires informed consent and on-site visits.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Sheng Qi
• Email: sheng.qi@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.