NCT07444086

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.

Conditions

• Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	QLC7401	QLC7401 Injection
DRUG	Placebo	Placebo matching QLC7401 in appearance and administration.

Timeline

• Start date: 2026-03-05
• Primary completion: 2027-10-07
• Completion: 2028-02-28
• First posted: 2026-03-02
• Last updated: 2026-03-02