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Clinical Trials in China / NCT07229937
Recruiting Phase 2

A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia

NCT07229937 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 2
Started
2025-11-25
Last updated
2025-12-12

Condition(s) studied

Hyperlipidemia

Investigational drug(s) / intervention(s)

HRS-1301HRS-1301HRS-1301HRS-1301Placebo

HRS-1301: HRS-1301 Dose 1,oral

HRS-1301: HRS-1301 Dose 2,oral

HRS-1301: HRS-1301 Dose 3,oral

HRS-1301: HRS-1301 Dose 4,oral

Placebo: Placebo,oral

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The 2nd Affiliated Hospital of Harbin Harbin Heilongjiang Recruiting

More Shandong Suncadia Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07229937 on ClinicalTrials.gov ↗ ← All trials in China