QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
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
1 other identifier
interventional
510
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedStudy Start
First participant enrolled
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
March 2, 2026
February 1, 2026
1.6 years
February 23, 2026
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline
From baseline to Day 330
Secondary Outcomes (3)
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)
Day 90 to Day 360
Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs)
From baseline to Day 360
Study Arms (2)
QLC7401
EXPERIMENTALPlacebo Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2026
First Posted
March 2, 2026
Study Start
March 5, 2026
Primary Completion (Estimated)
October 7, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share