NCT07441317

QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of QLC7401 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia With Poorly Controlled Low-density Lipoprotein Cholesterol (LDL-C) Elevated on Optimized Lipid-lowering Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy, safety and immunogenicity of QCL7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.

Conditions

• Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	QLC7401	QLC7401 combined with lipid-lowering agents
DRUG	Placebo	Placebo combined with lipid-lowering agents

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2026-02-27
• Last updated: 2026-03-04