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QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

NCT07444086 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

  • Primary Hypercholesterolemia or Mixed Hyperlipidemia

Interventions

DRUG

QLC7401

QLC7401 Injection

DRUG

Placebo

Placebo matching QLC7401 in appearance and administration.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2027-10-07
Completion
2028-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444086 on ClinicalTrials.gov