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

NCT07441317 | Not Yet Recruiting Phase 3

• 1 other identifier: QLC7401-301
• Study Type: interventional
• Target: 780
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C)

  From baseline to Day 330

Secondary Outcomes (3)

• 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]

Study Arms (2)

QLC7401 Injection

EXPERIMENTAL

Participants receive QLC7401 at a pre-defined dosage via subcutaneous injection according to the study schedule.

Drug: QLC7401

Placebo

PLACEBO COMPARATOR

Participants receive placebo via subcutaneous injection according to the study schedule.

Drug: Placebo

Interventions

QLC7401 DRUG

QLC7401 combined with lipid-lowering agents

QLC7401 Injection

Placebo DRUG

Placebo combined with lipid-lowering agents

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged ≥18 years of age.
• 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.
• Fasting Total Cholesterol (TG) ≤400mg/dL (≤4.5mmol/L) at screening.
• Stable lipid-lowering therapy for ≥4 weeks at randomization.
• Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

You may not qualify if:

• 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.
• 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.
• 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.
• The investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jian an Wang, Doctorate

CONTACT

086-15990086511; wang_jian_an@vip.tom.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02