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

NCT07444086•Qilu Pharmaceutical Co., Ltd.

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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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged ≥18 years.
•Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and \<4.9 mmol/L at screening.
•Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines.
•Not currently on lipid-lowering therapy.
•estimated Glomerular Filtration Rate (eGFR) \>30 mL/min/1.73 m².
•Willing to provide informed consent.

Exclusion Criteria

•History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).
•Familial hypercholesterolemia.
•Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).
•Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c \>8.0%).
•Use of prohibited lipid-lowering drugs within specified washout periods.
•Significant liver or kidney disease.
•Pregnancy or lactation.
•Other conditions deemed unsuitable by investigator.

Key Dates

Start Date

March 5, 2026

Primary Completion Date

October 7, 2027

Completion Date

February 28, 2028

Last Updated

March 2, 2026

Enrollment

510

ESTIMATED participants

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

QLC7401

DRUG

Placebo

DRUG

Contacts

Yue Li, PhD

CONTACT

8613945057313 hydy_liyue@163.com

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

NCT07441317

Primary Hypercholesterolemia or Mixed Hyperlipidemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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