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NCT07450378Not yet recruitingPhase 3

QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
120 (estimated)
First submitted
27 Feb 2026
Start date
May 2026
Primary completion date
Apr 2028
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
NCT number
NCT07450378

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 120
  • From May 2026 to the primary completion date, Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.
  • Other conditions deemed unsuitable by investigator.

Other

  • Pregnancy or lactation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.