HRS-1301 for lowering high cholesterol (dyslipidemia)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, 12-week interventional study gives adults with dyslipidemia one of several doses of HRS-1301 or placebo to explore a reasonable dosage and measure efficacy and safety. Eligible participants include adults with BMI ≥18 and either established ASCVD with LDL-C ≥1.8 mmol/L or intermediate-to-high ASCVD risk with LDL-C ≥2.6 mmol/L. Key exclusions include very high triglycerides (>5.6 mmol/L), homozygous familial hypercholesterolemia, recent acute ASCVD events, advanced heart failure, recent malignancy, or recent LDL/plasma apheresis. The trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and conducted at The 2nd Affiliated Hospital of Harbin in Harbin, Heilongjiang, China.

Why it matters

Who can join: the full rules

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

Where it's running

• The 2nd Affiliated Hospital of Harbin
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Miaomiao Shi
• Email: Miaomiao.shi@hengrui.com
• Phone: 18036617171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.