Actively Recruiting
A Trial 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
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Both men and women are eligible
- Receiving a stable dose of statins at screening
- Fasting LDL-C meets: ≥1.4 mmol/L for extremely high ASCVD risk; ≥1.8 mmol/L for very high ASCVD risk; ≥2.6 mmol/L for medium and high ASCVD risk
- Fasting triglycerides ≥1.7 mmol/L
- Understands study procedures, voluntarily agrees to participate, and signs informed consent
You will not qualify if you...
- Poorly controlled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) at screening or before randomization
- ALT, AST, or γ-glutamyl transferase (GGT) levels more than 3 times the upper limit of normal (ULN), or total bilirubin more than 2 times ULN
- Thyroid stimulating hormone (TSH) below the lower limit of normal or greater than 1.5 times ULN
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m²
- History of diseases significantly impacting 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
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
CONTACT
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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