Hyperlipidemia
Conditions
Brief summary
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.
Interventions
DRUGHRS-1301
HRS-1301 Dose 1，oral
DRUGPlacebo
Placebo，oral
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female ≥ 18 years old, who is able and willing to provide a written informed consent 2. BMI ≥ 18.0 kg/m2 3. 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 4. 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
Exclusion criteria
1. TG \> 5.6 mmol/L 2. Diagnosed with homozygous familial hypercholesterolemia (HoFH) 3. Acute ischemic ASCVD events within 12 months before screening, or during the screening and run-in phase 4. Heart failure with New York Heart Association (NYHA) Class III-IV 5. Malignant tumors within 5 years 6. Received or is regularly receiving LDL or plasma apheresis within 12 months before screening 7. History or presence of severe gastrointestinal, hepatic, or renal diseases, or other known diseases that may interfere with drug absorption, distribution, metabolism, or excretion 8. Uncontrolled diabetes mellitus and/or hypertension 9. Has undergone transplantation of any vital organ, such as lung, liver, heart, bone marrow, or kidney
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in LDL-C relative to baseline | at 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in HDL-C relative to baseline； | at 12 weeks of treatment |
| Percentage change in TG relative to baseline； | at 12 weeks of treatment |
| Proportion of subjects achieving LDL-C goals | at 12 weeks of treatment |
| Percentage change in non-HDL-C relative to baseline； | at 12 weeks of treatment |
| Percentage change in TC relative to baseline； | at 12 weeks of treatment |
| Percentage change in ApoA1 relative to baseline； | at 12 weeks of treatment； |
| Percentage change in Lp(a) relative to baseline； | at 12 weeks of treatment； |
| Percentage change in hsCRP relative to baseline； | at 12 weeks of treatment； |
| Number of participants with one or more adverse events | during the study period；Approximately half a year |
| Percentage change in ApoB relative to baseline； | at 12 weeks of treatment |
Countries
China
Contacts
Primary ContactMiaomiao Shi
Outcome results
None listed