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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia
• Intervention / Treatment: Drug: QLC7401; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jian an Wang, Doctorate; Phone Number: 086-15990086511; Email: wang_jian_an@vip.tom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLC7401 Injection; Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule.	Drug: QLC7401; QLC7401 combined with lipid-lowering agents
Placebo Comparator: Placebo; Participants receive placebo via subcutaneous injection according to the study schedule.	Drug: Placebo; Placebo combined with lipid-lowering agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)	From baseline to Day 330

Secondary Outcome Measures

Outcome Measure	Time Frame
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C	Day 90 to Day 360
Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline	From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs	Throughout the study duration]

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hyperlipoproteinemia Type II
• Other Study ID Numbers: QLC7401-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No