RecruitingPhase 2NCT07229937

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of HRS-1301 in Participants With Dyslipidemia

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

189 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperlipidemia

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria9

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