NCT07450378

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

Type	Name	Description
DRUG	QLC7401 Injection	QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.
DRUG	Placebo	Placebo matching QLC7401 in appearance and administration.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-04-01
• Completion: 2028-07-01
• First posted: 2026-03-04
• Last updated: 2026-03-04