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QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

ConditionPrimary Hypercholesterolemia or Mixed Hyperlipidemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%).

Trial design

Design model

Parallel

Treatments tested in this trial

  • QLC7401

    Drug

    QLC7401 Injection

  • Placebo

    Drug

    Placebo matching QLC7401 in appearance and administration.

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: QLC7401Experimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline

Time frame
From baseline to Day 330

Secondary outcomes

1

Time-adjusted Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)

Time frame
Day 90 to Day 360
2

Change in concentration of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) from Baseline

Time frame
From baseline to Day 360
3

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
From baseline to Day 360

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: