Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07230730

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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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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