---
title: QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
nct_id: NCT07444086
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: Qilu Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Primary Hypercholesterolemia or Mixed Hyperlipidemia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07444086.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07444086"
ct_last_update_post_date: 2026-03-02
last_seen_at: "2026-05-12T07:04:24.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

**Official Title:** 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

**NCT ID:** [NCT07444086](https://clinicaltrials.gov/study/NCT07444086)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 510
- **Lead Sponsor:** Qilu Pharmaceutical Co., Ltd.
- **Conditions:** Primary Hypercholesterolemia or Mixed Hyperlipidemia
- **Start Date:** 2026-03-05
- **Completion Date:** 2028-02-28
- **CT.gov Last Update:** 2026-03-02

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **QLC7401** (EXPERIMENTAL)
- **Placebo Group** (PLACEBO_COMPARATOR)

## Interventions

- **QLC7401** (DRUG) — QLC7401 Injection
- **Placebo** (DRUG) — Placebo matching QLC7401 in appearance and administration.

## Primary Outcomes

- **Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline** _(time frame: From baseline to Day 330)_

## Secondary Outcomes

- **Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)** _(time frame: 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)_
- **Incidence of Treatment-Emergent Adverse Events (TEAEs)** _(time frame: From baseline to Day 360)_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07444086.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07444086*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*