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OpenTrials
Completed

NCT Number: NCT06109831

Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic

This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regularly taking any moderate-intensity or higher dose* of statin stabilization therapy for ≥4 weeks at screening:
  • ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
  • ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
  • ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
  • Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose* statin stabilization therapy for ≥4 weeks;

a) Fasting LDL-C ≥ 2.6 mmol/L.

  • Fasting triglycerides ≤ 5.6 mmol/L.

Exclusion criteria

  • Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%).
  • eGFR <30ml/min/1.73m2 at the screening visit.
  • CK >5times ULN at the screening visit.

Treatment and study plan

SHR-1918

Drug

SHR-1918

SHR-1918 placebo

Drug

SHR-1918 placebo

Primary outcomes

  1. Percent change in calculated LDL-C from baseline to week 16

    Time frame: from baseline to week 16

Secondary outcomes

  1. Change in calculated LDL-C from baseline to week 16

    Time frame: from baseline to week 16

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.