QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

February 27, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

Evaluation of Efficacy and Safety of QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo matching QLC7401 in appearance and administration.
Experimental: QLC7401 Injection
Drug: QLC7401 Injection
QLC7401 is a small interfering RNA (siRNA) targeting PCSK9. Administered as subcutaneous injection at a specified dose level.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • QLC7401-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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