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NCT Number: NCT07444086

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.

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Key information

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years.
  • Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and <4.9 mmol/L at screening.
  • Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines.
  • Not currently on lipid-lowering therapy.
  • estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m².
  • Willing to provide informed consent.

Exclusion criteria

  • History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).
  • Familial hypercholesterolemia.
  • Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).
  • Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c >8.0%).
  • Use of prohibited lipid-lowering drugs within specified washout periods.
  • Significant liver or kidney disease.
  • Pregnancy or lactation.
  • Other conditions deemed unsuitable by investigator.

Treatment and study plan

QLC7401

Drug

QLC7401 Injection

Placebo

Drug

Placebo matching QLC7401 in appearance and administration.

Primary outcomes

  1. Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline

    Time frame: From baseline to Day 330

Secondary outcomes

  1. Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Day 90 to Day 360

  2. Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline

    Time frame: From baseline to Day 360

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From baseline to Day 360

Study contacts

Contact information is provided by the study sponsor or research team.

Yue Li, PhD

CONTACT

[email protected]

8613945057313

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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