QLC7401 Monotherapy in Non-familial Hypercholesterolemia... | NCT07444086

Studies
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

NCT07444086

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Mar 2, 2026Actual

Enrollment

510Estimated

Phase

Phase 3

Conditions

Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

QLC7401
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2026Estimated

Primary Completion Date

Oct 7, 2027Estimated

Completion Date

Feb 28, 2028Estimated

First Submitted Date

Feb 23, 2026

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Mar 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

510Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QLC7401	Experimental		Drug: QLC7401
Placebo Group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QLC7401	Drug	QLC7401 Injection	QLC7401
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Yue Li, PhD	Contact	8613945057313		hydy_liyue@163.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006938	Hyperlipoproteinemia Type II

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

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Browse Branches

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