Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
Led by Beijing Suncadia Pharmaceuticals Co., Ltd · Updated on 2026-05-14
900
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of SHR-1918 in lowering serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia, compared to a placebo. The study also aims to assess SHR-1918's impact on other lipid markers in patients with mixed hyperlipidemia. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Participants are assigned randomly to receive either a low or high dose of SHR-1918 or matching placebo. The treatment period lasts 24 weeks, during which changes in LDL-C, TG, and other lipid indicators are measured. The study includes an additional follow-up period up to 52 weeks to assess safety outcomes such as adverse events, injection site reactions, and major cardiovascular events. Throughout the trial, participants undergo regular assessments of blood lipid levels including LDL-C, triglycerides, non-HDL cholesterol, total cholesterol, apolipoproteins, and lipoprotein(a) at baseline, week 24, and week 48. Safety is monitored continuously up to week 52 with attention to cardiovascular events and injection site reactions. The study duration allows for comprehensive evaluation of both efficacy and safety over nearly a year of participation.
CONDITIONS
Brief Title
A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, men and women eligible
- Receiving a stable dose of statins at screening
- Fasting LDL-C levels meeting risk-specific thresholds: ≥1.4 mmol/L for extremely high ASCVD risk, ≥1.8 mmol/L for very high risk, ≥2.6 mmol/L for medium and high risk
- Fasting triglycerides ≥1.7 mmol/L
- Able to understand study procedures and voluntarily sign informed consent
You will not qualify if you...
- Poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)
- Elevated liver enzymes (ALT, AST, or GGT >3 times upper limit of normal) or total bilirubin >2 times upper limit of normal
- Thyroid stimulating hormone (TSH) outside normal range or greater than 1.5 times upper limit of normal
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2
- History of diseases significantly affecting blood lipid levels such as nephrotic syndrome, severe liver diseases, or Cushing's syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either SHR-1918 or placebo to evaluate the efficacy and safety of the drug in treating hyperlipidemia.
Baseline visit and regular visits until Week 24
Duration - 28 weeks
Participants are monitored for safety and effectiveness outcomes after treatment completion.
Periodic visits up to Week 52
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
S
Sheng Qi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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