Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia

Treatments: Drug: QLC7401; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06750341

QLC7401-201

Details and patient eligibility

About

To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized lipid-lowering therapy.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants aged ≥18 years of age.
• Serum LDL-C ≥1.8mmol/L for ASCVD participants or ≥2.6mmol/L for other participants at screening.
• Fasting 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.

Exclusion criteria

• Having the following diseases or treatment history: (1) cardiac function as defined by the New York Heart Association (NYHA) grade II-IV at screening or randomization or latest detected LVEF<30%; (2) CVD events 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 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 4 patient groups, including a placebo group

QLC7401 100mg

Experimental group

Description:

QLC7401 100 mg subcutaneous injection

Treatment:

Drug: QLC7401

QLC7401 300mg

Experimental group

Description:

QLC7401 300 mg subcutaneous injection

Treatment:

Drug: QLC7401

QLC7401 500mg

Experimental group

Description:

QLC7401 500 mg subcutaneous injection

Treatment:

Drug: QLC7401

Placebo

Placebo Comparator group

Description:

Placebo 100/300/500 mg subcutaneous injection

Treatment:

Drug: Placebo