What is HRS-1301 studying for dyslipidemia?

HRS-1301 is being studied to find the right dose and to evaluate its effects and safety in people with dyslipidemia. This condition involves abnormal blood lipid levels that increase cardiovascular risk. The research is conducted by Shandong Suncadia Medicine Co., Ltd. to better understand how this drug might help manage cholesterol levels.

Who may be eligible for this dyslipidemia clinical trial?

Adults aged 18 years or older with clinical diagnosis of atherosclerotic cardiovascular disease or at intermediate to high risk for it may be eligible. Both men and women can participate. Key factors include specific cholesterol levels and overall health status. Please review eligibility criteria for more details.

Is there any cost to participate in this dyslipidemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07229937

Phase 2 Study of HRS-1301 for Treating Dyslipidemia Evaluating Effectiveness and Safety with Different Doses in Adults

Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-12-12

189

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Miaomiao Shi

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