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NCT Number: NCT06723652

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).

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Key information

Conditions

Homozygous Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, 410000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
  • LDL-C ≥2.6mmol/L at the screening visit
  • Body weight ≥40 kg
  • Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion criteria

  • Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
  • 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

six administration

SHR-1918 placebo

Drug

SHR-1918 placebo three administration+SHR-1918 three administration

Primary outcomes

  1. Percent change in calculated LDL-C from baseline to week 12

    Time frame: week 12

Secondary outcomes

  1. Change in calculated LDL-C from baseline to week 12

    Time frame: week 12

  2. Percent change and changer in calculated LDL-C from baseline to week 24

    Time frame: week 24

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 15, 2025

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.

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