Actively Recruiting
A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-12-12
189
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older who can provide written informed consent
- Body mass index (BMI) of 18.0 kg/m2 or higher
- Clinically diagnosed with ASCVD and LDL-C 1.8 mmol/L or higher, or if no ASCVD, has intermediate to high risk of ASCVD and LDL-C 2.6 mmol/L or higher
- Male and female participants of childbearing potential and their partners must agree to use contraception and avoid donating sperm or pregnancy during the study and for 2 weeks after last dose
You will not qualify if you...
- Triglycerides (TG) greater than 5.6 mmol/L
- Diagnosed with homozygous familial hypercholesterolemia (HoFH)
- Acute ischemic ASCVD events within 12 months before screening or during screening and run-in phase
- Heart failure classified as New York Heart Association (NYHA) Class III-IV
- History of malignant tumors within 5 years
- Received or regularly receiving LDL or plasma apheresis within 12 months before screening
- Severe gastrointestinal, hepatic, or renal diseases or other conditions interfering with drug absorption, distribution, metabolism, or excretion
- Uncontrolled diabetes mellitus and/or hypertension
- History of transplantation of vital organs such as lung, liver, heart, bone marrow, or kidney
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The 2nd Affiliated Hospital of Harbin
Harbin, Heilongjiang, China, 150086
Actively Recruiting
Research Team
M
Miaomiao Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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