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

NCT07441317•Qilu Pharmaceutical Co., Ltd.

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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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female participants aged ≥18 years of age.
•2. Serum low density lipoprotein cholesterol (LDL-C) ≥1.8mmol/L for participants with atherosclerotic cardiovascular disease (ASCVD) or ≥2.6mmol/L for other participants at screening.
•3. Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening.
•4. Stable lipid-lowering therapy for ≥4 weeks at randomization.
•5. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria

•1. Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization ; (2) Cardiovascular diseases within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other RNA inhibitors within 2 years.
•2. Any of the laboratory indicators met the following criteria at screening or at randomization: (1) ALT or AST exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times ULN; (2) creatine kinase (CK) exceeding 3 times ULN; (3) TSH is less than the lower limit or normal (LLN) or exceeds 1.5 times ULN.
•3. General conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating.
•4. The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 1, 2027

Completion Date

March 1, 2028

Last Updated

March 4, 2026

Enrollment

780

ESTIMATED participants

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

QLC7401

DRUG

Placebo

DRUG

Contacts

Jian an Wang, Doctorate

CONTACT

086-15990086511 wang_jian_an@vip.tom.com

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

NCT07444086

Primary Hypercholesterolemia or Mixed Hyperlipidemia

View study

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 4, 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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