The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.
Male and female ≥ 18 years old, who is able and willing to provide a written informed consent
BMI ≥ 18.0 kg/m2
Clinically diagnosed with ASCVD and LDL-C ≥ 1.8 mmol/L OR, if no history of ASCVD, has intermediate to high risk of developing ASCVD and LDL-C ≥ 2.6 mmol/L
Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and for 2 weeks after the last dose, and agree to use contraceptive methods as specified in the protocol
TG > 5.6 mmol/L
Diagnosed with homozygous familial hypercholesterolemia (HoFH)
Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase
Heart failure with New York Heart Association (NYHA) Class III-IV