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Not yet recruiting NCT06750341

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

Phase II 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 II Clinical Study to Evaluate the Efficacy and Safety of Different Doses 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, 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.

Interventions

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

Primary outcome measures

  • Percentage changes in LDL-C from baseline to Day 180 and Day 270 [Time frame: 80 days and 270 days]
Secondary outcome measures (11)
  • Percentage changes in LDL-C from baseline at each subsequent visit to Day 360 [Time frame: 360 days]
  • Value changes in LDL-C from baseline at each subsequent visit to Day 360 [Time frame: 360 days]
  • Percentage changes in PCSK9 from baseline at each subsequent visit to Day 360 [Time frame: 360 days]
  • Value changes in PCSK9 from baseline at each subsequent visit to Day 360 [Time frame: 360 days]
  • Percentage changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360 [Time frame: 360 days]
  • Value changes in non-HDL-C, Apo B, TC/HDL-C, Apo A1, Apo B/Apo A1, Lp (a), and TG from baseline to Day 180, Day 270, and Day 360 [Time frame: 360 days]
  • Proportion of participants with LDL-C greater than 80% of baseline value at Day 180, Day 210, Day 270, and Day 360 [Time frame: 360 days]
  • Duration of treatment for participants to return to 80% of baseline value or greater LDL-C or PCSK9 protein [Time frame: 360 days]
  • Proportion of participants who attained global lipid modification targets for level of ASCVD risk [Time frame: 360 days]
  • Number of participants with adverse events and injection site reactions, with abnormal vital signs, abnormal physical examination, abnormal 12-ECG, abnormal laboratory assessments [Time frame: 360 days]
  • ADA incidence [Time frame: 360 days]

Eligibility criteria

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.

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: NCT06750341 · QLC7401-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗