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Tests treatment safety and results for Hyperlipidemia
Official title A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
ClinicalTrials.gov ID: NCT07229937
What this study is testing
What is HRS-1301?
HRS-1301 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hyperlipidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Male and female people of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study...
You likely can't join 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
See the full eligibility criteria
- 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 people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, Heilongjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, Heilongjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.