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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT07229937

Run by

Shandong Suncadia Medicine Co., Ltd.

People needed

189

Starts

2025-11-25

Expected to finish

2026-08-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Malignant tumors within 5 years
• Received or is regularly receiving LDL or plasma apheresis within 12 months before screening
• History or presence of severe gastrointestinal, hepatic, or renal diseases, or other known diseases that may interfere with drug absorption, distribution, metabolism, or excretion
• Uncontrolled diabetes mellitus and/or hypertension
• Has undergone transplantation of any vital organ, such as lung, liver, heart, bone marrow, or kidney

Where it is running

• The 2nd Affiliated Hospital of Harbin — Harbin, Heilongjiang, China (enrolling)

Full record on ClinicalTrials.gov

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