Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the appropriate dosage of HRS-1301 in adults with dyslipidemia, a condition involving abnormal lipid levels in the blood. This phase II trial aims to assess both the effectiveness and safety of HRS-1301 after 12 weeks of treatment. The study is led by Shandong Suncadia Medicine Co., Ltd. and involves participants with varying degrees of cardiovascular risk and cholesterol levels. Participants will be randomly assigned to one of several groups receiving different oral doses of HRS-1301 or a placebo. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the drug or placebo during the treatment period. Treatment lasts 12 weeks, with doses ranging across multiple groups to determine the most suitable amount. During the trial, participants will have their cholesterol levels and related markers regularly monitored to measure changes from baseline. The primary outcome focuses on the percentage change in LDL cholesterol after 12 weeks. Secondary outcomes include changes in total cholesterol, HDL, triglycerides, other lipid markers, and inflammation levels. Safety will be monitored by recording adverse events over approximately six months. Participants will attend scheduled visits for assessments throughout the study.
CONDITIONS
Brief 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 and 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 atherosclerotic cardiovascular disease (ASCVD) and LDL-C at or above 1.8 mmol/L, or if no ASCVD history, intermediate to high risk of ASCVD with LDL-C at or above 2.6 mmol/L
- Male and female participants of childbearing potential and their partners agree to use contraception and avoid sperm donation or pregnancy during the study and for 2 weeks after last dose
You will not qualify if you...
- Triglycerides (TG) higher than 5.6 mmol/L
- Diagnosis of 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
- Malignant tumors within the past 5 years
- Receipt of or regular LDL or plasma apheresis within 12 months before screening
- History or presence of severe gastrointestinal, liver, or kidney diseases, or other conditions affecting drug absorption or metabolism
- Uncontrolled diabetes mellitus 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive oral doses of HRS-1301 or placebo to evaluate efficacy and safety for dyslipidemia.
Regular visits during the 12-week treatment period
Duration - Approximately 12 weeks
Participants are observed for safety and adverse events after the treatment period.
Visits as scheduled during follow-up
Trial Site Locations
Total: 1 location
1
The 2nd Affiliated Hospital of Harbin
Harbin, Heilongjiang, China, 150086
Actively Recruiting
Research Team
M
Miaomiao Shi
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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