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

NCT ID: NCT06750341

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hypercholesterolemia or Mixed Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QLC7401 100mg

QLC7401 100 mg subcutaneous injection

Group Type EXPERIMENTAL

QLC7401

Intervention Type DRUG

QLC7401 combined with lipid-lowering agents

QLC7401 300mg

QLC7401 300 mg subcutaneous injection

Group Type EXPERIMENTAL

QLC7401

Intervention Type DRUG

QLC7401 combined with lipid-lowering agents

QLC7401 500mg

QLC7401 500 mg subcutaneous injection

Group Type EXPERIMENTAL

QLC7401

Intervention Type DRUG

QLC7401 combined with lipid-lowering agents

Placebo

Placebo 100/300/500 mg subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo combined with lipid-lowering agents

Interventions

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QLC7401

QLC7401 combined with lipid-lowering agents

Intervention Type DRUG

Placebo

Placebo combined with lipid-lowering agents

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ming Zhao

Role: CONTACT

Phone: 086+15666662408

Email: [email protected]

Other Identifiers

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QLC7401-201

Identifier Type: -

Identifier Source: org_study_id