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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07444086

Enrollment

510

Registered

2026-03-02

Start date

2026-03-05

Completion date

2028-02-28

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

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.

Interventions

DRUGQLC7401

QLC7401 Injection

DRUGPlacebo

Placebo matching QLC7401 in appearance and administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline	From baseline to Day 330

Secondary

Measure	Time frame
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

Contacts

CONTACTYue Li, PhD

hydy_liyue@163.com8613945057313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026