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NCT Number: NCT07450378

QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-80 years (inclusive)
  • Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic
  • Network criteria or genetic testing;
  • Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)/liter (L) at screening.
  • Fasting triglyceride <4.5 mmol/L at screening.
  • Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation.
  • Estimated glomerular filtration Rate (eGFR) >30 mL/min/1.73 m².
  • Willing to provide informed consent.

Exclusion criteria

  • New York Heart Association (NYHA) class III or IV heart failure.
  • Uncontrolled cardiac arrhythmia.
  • Cardiovascular Diseases within 3 months.
  • Uncontrolled hypertension.
  • Poorly controlled type 2 diabetes.
  • Significant liver or kidney disease.
  • Pregnancy or lactation.
  • Other conditions deemed unsuitable by investigator.

Treatment and study plan

QLC7401 injection

Drug

QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.

Placebo

Drug

Placebo matching QLC7401 in appearance and administration.

Primary outcomes

  1. Percent Change in LDL-C from Baseline

    Time frame: From baseline to Day 360

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: From baseline to Day 360

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Lin, PhD

CONTACT

[email protected]

86 135 2183 6273

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Mar 4, 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.

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