QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
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
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
Treatments tested in this trial
- QLC7401
- Placebo
Treatment groups
510 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov