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NCT Number: NCT07230730

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Jianan Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-1918

Drug

SHR-1918

SHR-1918 placebo

Drug

SHR-1918 placebo

Primary outcomes

  1. The percentage change of serum LDL-C from baseline;

    Time frame: Baseline and Week 24

  2. The percentage change in serum TG from baseline;

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline;

    Time frame: Baseline and Week 24

  2. The percentage change in serum total cholesterol (TC) from baseline;

    Time frame: Baseline and Week 24

  3. The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24;

    Time frame: Baseline and Week 24

  4. The percentage change of serum apolipoprotein A1 (ApoA1) from baseline;

    Time frame: Baseline and Week 24

  5. The change from baseline in serum LDL-C;

    Time frame: Baseline and Week 24

  6. The change from baseline in serum TG;

    Time frame: Baseline and Week 24

  7. The change from baseline in serum non-HDL-C;

    Time frame: Baseline and Week 24

  8. The change from baseline in serum TC;

    Time frame: Baseline and Week 24

  9. The change from baseline in serum ApoB;

    Time frame: Baseline and Week 24

  10. The change from baseline in serum ApoA1;

    Time frame: Baseline and Week 24

  11. Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a));

    Time frame: Baseline and Week 24

  12. Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C);

    Time frame: Baseline and Week 24

  13. LDL-C goal attainment rates at Week 24, overall and by risk subgroup;

    Time frame: Baseline and Week 24

  14. Absolute and percentage change from baseline in serum non-HDL-C at Week 48;

    Time frame: Baseline and Week 48

  15. Absolute and percentage change from baseline in serum ApoB at Week 48;

    Time frame: Baseline and Week 48

  16. Absolute and percentage change from baseline in serum Lp(a) at Week 48;

    Time frame: Baseline and Week 48

  17. Absolute and percentage change from baseline in serum TC at Week 48;

    Time frame: Baseline and Week 48

  18. Absolute and percentage change from baseline in serum TG at Week 48;

    Time frame: Baseline and Week 48

  19. Absolute and percentage change from baseline in serum HDL-C at Week 48;

    Time frame: Baseline and Week 48

  20. Absolute and percentage change from baseline in serum ApoA1 at Week 48;

    Time frame: Baseline and Week 48

  21. LDL-C goal attainment rates at Week 48, overall and by risk subgroup

    Time frame: Baseline and Week 48

  22. The incidence and severity of adverse events (AEs) throughout the study;

    Time frame: up to week 52

  23. Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study;

    Time frame: up to week 52

  24. Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study;

    Time frame: up to week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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