QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

February 25, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

510

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 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.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Drug: Placebo
Placebo matching QLC7401 in appearance and administration.
Experimental: QLC7401
Drug: QLC7401
QLC7401 Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Day 90 to Day 360
Day 90 to Day 360
Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline
Time Frame: From baseline to Day 360
From baseline to Day 360
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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)

March 5, 2026

Primary Completion (Estimated)

October 7, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLC7401-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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