Not Yet RecruitingPhase 3

A Study of SHR-1918 In Participants With Hypertriglyceridemia

China360 participantsStarted 2026-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: at 20 weeks and 24 weeks of treatment

Trial details

NCT IDNCT07349615

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Miaomiao Shi

18036617171 Miaomiao.shi@hengrui.com

View on ClinicalTrials.gov More Hypertriglyceridemia trials