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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07450378

Enrollment

120

Registered

2026-03-04

Start date

2026-05-01

Completion date

2028-07-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Brief summary

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.

Interventions

DRUGQLC7401 Injection

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

DRUGPlacebo

Placebo matching QLC7401 in appearance and administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percent Change in LDL-C from Baseline	From baseline to Day 360

Secondary

Measure	Time frame
Incidence of Treatment-Emergent Adverse Events	From baseline to Day 360

Contacts

CONTACTJie Lin, PhD

Linjie1998@126.com86 135 2183 6273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026