QLC7401 in Participants With Heterozygous Familial Hyperc... | NCT07450378

Studies
QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT07450378

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Mar 4, 2026Actual

Enrollment

120Estimated

Phase

Phase 3

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

QLC7401 Injection
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

May 2026Estimated

Primary Completion Date

Apr 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Feb 27, 2026

First Submission Date that Met QC Criteria

Feb 27, 2026

First Posted Date

Mar 4, 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 27, 2026

Last Update Posted Date

Mar 4, 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 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable 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

120Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QLC7401 Injection	Drug	QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.	QLC7401 Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change in LDL-C from Baseline		From baseline to Day 360

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events		From baseline to Day 360

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18-80 years (inclusive)
Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic
Network criteria or genetic testing;
Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)/liter (L) at screening.
Fasting triglyceride <4.5 mmol/L at screening.
Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation.
Estimated glomerular filtration Rate (eGFR) >30 mL/min/1.73 m².
Willing to provide informed consent.

Exclusion Criteria:

New York Heart Association (NYHA) class III or IV heart failure.
Uncontrolled cardiac arrhythmia.
Cardiovascular Diseases within 3 months.
Uncontrolled hypertension.
Poorly controlled type 2 diabetes.
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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided