NCT07349615
Not yet recruiting
Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia
Beijing Suncadia Pharmaceuticals Co., Ltd1 site in 1 country360 target enrollmentStarted: February 1, 2026Last updated:
InterventionsSHR-1918/ SHR-1918 placebo
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；
Experimental
Intervention: SHR-1918/ SHR-1918 placebo (Drug)
SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；
Experimental
Intervention: SHR-1918/ SHR-1918 placebo (Drug)
Outcomes
Primary Outcomes
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
- Percentage change in non-HDL-C relative to baseline(at 24 weeks of treatment)
- Percentage change in LDL-C relative to baseline；(at 24 weeks of treatment)
- Percentage change in TC relative to baseline；(at 24 weeks of treatment；)
- Percentage change in ApoB relative to baseline；(at 24 weeks of treatment；)
- Percentage change in ApoA1 relative to baseline；(at 24 weeks of treatment；)
- Change in TG relative to baseline；(at 24 weeks of treatment；)
- Change in non-HDL-C relative to baseline；(at 24 weeks of treatment；)
- Change in LDL-C relative to baseline；(at 24 weeks of treatment；)
- Change in TC relative to baseline；(at 24 weeks of treatment)
- Change in ApoB relative to baseline；(at 24 weeks of treatment；)
- Change in ApoA1 relative to baseline；(at 24 weeks of treatment；)
- Change and percentage change in Lp(a) relative to baseline；(at 24 weeks of treatment；)
- Change and percentage change in HDL-C relative to baseline；(at 24 weeks of treatment；)
- Proportion of subjects with TG < 1.7 mmol/L；(at 24 weeks and 48 weeks of treatment；)
- Change and percentage change in non-HDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in LDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in TC relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in ApoB relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in ApoA1 relative to baseline；(at 48 weeks of treatment)
- Change and percentage change in Lp(a) relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in HDL-C relative to baseline；(at 48 weeks of treatment；)
- Change and percentage change in TG relative to baseline；(at 48 weeks of treatment；)
- Proportion of subjects who received rescue treatment；(Approximately a year；)
- Incidence and severity of adverse events and injection site reactions(Approximately a year)
Investigators
Study Sites (1)
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