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NCT Number: NCT07349615

A Study of SHR-1918 In Participants With Hypertriglyceridemia

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Junbo Ge

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
  • 1.7 ≤ TG ≤ 5.6 mmol/L.
  • LDL-C < 3.4 mmol/L.
  • Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.

Exclusion criteria

  • History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
  • Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
  • Have a history of pancreatitis prior to screening or randomization.
  • Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  • Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
  • Malignant tumors within 5 years.
  • Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
  • Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
  • Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  • Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.

Treatment and study plan

SHR-1918/ SHR-1918 placebo

Drug

SHR-1918/ SHR-1918 placebo Dose 1

Primary outcomes

  1. Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline

    Time frame: at 20 weeks and 24 weeks of treatment

Secondary outcomes

  1. Percentage change in non-HDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  2. Percentage change in LDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  3. Percentage change in TC relative to baseline

    Time frame: at 24 weeks of treatment

  4. Percentage change in ApoB relative to baseline

    Time frame: at 24 weeks of treatment

  5. Percentage change in ApoA1 relative to baseline

    Time frame: at 24 weeks of treatment

  6. Change in TG relative to baseline

    Time frame: at 24 weeks of treatment

  7. Change in non-HDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  8. Change in LDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  9. Change in TC relative to baseline

    Time frame: at 24 weeks of treatment

  10. Change in ApoB relative to baseline

    Time frame: at 24 weeks of treatment

  11. Change in ApoA1 relative to baseline

    Time frame: at 24 weeks of treatment

  12. Change and percentage change in Lp(a) relative to baseline

    Time frame: at 24 weeks of treatment

  13. Change and percentage change in HDL-C relative to baseline

    Time frame: at 24 weeks of treatment

  14. Proportion of subjects with TG < 1.7 mmol/L

    Time frame: at 24 weeks and 48 weeks of treatment

  15. Change and percentage change in non-HDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  16. Change and percentage change in LDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  17. Change and percentage change in TC relative to baseline

    Time frame: at 48 weeks of treatment

  18. Change and percentage change in ApoB relative to baseline

    Time frame: at 48 weeks of treatment

  19. Change and percentage change in ApoA1 relative to baseline

    Time frame: at 48 weeks of treatment

  20. Change and percentage change in Lp(a) relative to baseline

    Time frame: at 48 weeks of treatment

  21. Change and percentage change in HDL-C relative to baseline

    Time frame: at 48 weeks of treatment

  22. Change and percentage change in TG relative to baseline

    Time frame: at 48 weeks of treatment

  23. Proportion of subjects who received rescue treatment

    Time frame: Approximately a year

  24. Incidence and severity of adverse events and injection site reactions

    Time frame: Approximately a year

Study contacts

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

Miaomiao Shi

CONTACT

[email protected]

18036617171

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 Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jun 16, 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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