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New treatment option for Hypercholesterolemia
Official title A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors
ClinicalTrials.gov ID: NCT07404553
What this study is testing
What is SHR-1918 Injection?
SHR-1918 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hypercholesterolemia.
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 evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
- TG ≤ 5.6 mmol/L.
- LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
- 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
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator...
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
- Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.
- History of percutaneous coronary intervention, history of coronary artery bypass grafting (CABG), history of peripheral arterial revascularisation...
See the full eligibility criteria
- Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.
- TG ≤ 5.6 mmol/L.
- LDL-C ≥ 2.6 mmol/L for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol/L for very high ASCVD risk, LDL-C ≥ 1.4 mmol/L for ultra-high ASCVD risk.
- 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 after the last dose, and agree to use contraceptive methods as...
- History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
- Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
- Acute ischemic ASCVD events within 3 months prior to screening or randomization.
- Have severe cardiac arrhythmia within 3 months prior to screening or randomization.
- Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.
- History of percutaneous coronary intervention, history of coronary artery bypass grafting (CABG), history of peripheral arterial revascularisation within 1 month prior to screening or randomization.
- Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
- Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.
- Malignant tumors within 5 years.
- It's planned to research transcutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery reconstruction, pacemaker implantation, cardiac resynchronisation therapy (CRT), implantable...
- Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.
- Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.
- History of drug use, substance abuse, and alcohol abuse.
- Participated in or is participating in other clinical studies and has received study interventions within the past month prior to screening.
- Researchers determine that the subject has poor compliance or any factors that make them unsuitable for participation in this trial, including but not limited to participation in the study placing the subject at...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.