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Not yet recruiting NCT07441317

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

Phase III Interventional Primary Hypercholesterolemia or Mixed Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLC7401, Placebo.
Who it may be relevant to
Registry conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug QLC7401
    QLC7401 combined with lipid-lowering agents
  • Drug Placebo
    Placebo combined with lipid-lowering agents

Primary outcome measures

  • Percentage changes in Low Density Lipoprotein Cholesterol (LDL-C) [Time frame: From baseline to Day 330]
Secondary outcome measures (3)
  • Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C [Time frame: Day 90 to Day 360]
  • Change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline [Time frame: From baseline to Day 360]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs [Time frame: Throughout the study duration]]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07441317 · QLC7401-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗