NCT07450378

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
23mo left

Started May 2026

Status
not yet recruiting

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

Study Progress12%
May 2026Jul 2028

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Outcome Measures

Primary Outcomes (1)

  • Percent Change in LDL-C from Baseline

    From baseline to Day 360

Secondary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    From baseline to Day 360

Study Arms (2)

QLC7401 Injection

EXPERIMENTAL
Drug: QLC7401 Injection

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QLC7401 InjectionDRUG

QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.

QLC7401 Injection
PlaceboDRUG

Placebo matching QLC7401 in appearance and administration.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jie Lin, PhD

CONTACT

86 135 2183 6273Linjie1998@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02