Phase 2 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who fully understand the study's purpose and methods, and are willing to sign a consent form before any assessments begin.
• Australian patients aged between 18 and 75 years (male or female).
• People who have been diagnosed with coronary artery disease (fatty buildup in the heart's arteries), with at least one artery showing narrowing detected by a specialised heart CT scan.
• Female participants must not be pregnant or breastfeeding. Women who could become pregnant (including female partners of male participants) must agree to use an effective form of contraception from the screening period until 3 months after the last dose of the study drug. Male participants must agree not to donate sperm during this same period.
• People who are willing and able to follow the study requirements as agreed upon with the trial team.

Who may not be able to join:

• People who have taken part in another clinical trial using an experimental drug within the past 30 days (or longer, depending on how long that drug stays in the body).
• People who have previously received the study drug YN001.
• People who have had any vaccination within the 4 weeks before joining the study.
• People who cannot safely have a heart CT scan — for example, those with a known history of severe allergic reactions to contrast dye used in scans.
• People with severe narrowing affecting multiple heart arteries.
• People who had a major heart attack (specifically an ST-elevation heart attack) within the 2 weeks before joining the study.
• People who have had recurring or severe uncontrolled irregular heartbeats in the past 3 months, such as certain fast heart rhythms that cannot be controlled with medication.
• People who have previously had open-heart bypass surgery, a heart transplant, or heart valve surgery, or for whom any of these procedures are planned during the study.
• People who have had a heart stent procedure (PCI) within 4 weeks before joining the study, or who have one planned during the study.
• People with advanced heart failure (classified as NYHA Class III or IV), or whose heart pumping function is measured at below 40%.
• People who have had a stroke within the 6 months before joining the study (minor temporary episodes, known as TIAs, may not apply — confirm with trial site).
• People with a history of muscle disease or muscle pain, or who are considered at higher risk of serious muscle breakdown.
• People with a known history of inflammatory bowel disease, stomach or intestinal ulcers, or bleeding from the gut or rectum within the past 6 months.
• People who have not recovered from a serious illness or major surgery within 2 weeks before joining the study, or who have major surgery planned during the study period.
• People with a history of cancer, unless they have been cancer-free for more than 5 years, or their only cancer history was a type of non-aggressive skin cancer (basal or squamous cell).
• People with any type of autoimmune disease (where the immune system attacks the body's own tissues).
• People with allergies to multiple foods or medications, or known sensitivity to any component of the study drug.
• People whose life expectancy is less than 1 year.
• People whose blood pressure (top number) remains at 150 mmHg or above at their final screening visit, even while taking blood pressure medication.
• People with a genetic condition called familial hypercholesterolaemia (an inherited cause of very high cholesterol).
• People with very high triglyceride (blood fat) levels of 400 mg/dL (4.5 mmol/L) or above at their final screening visit.
• People with active liver disease or poor liver function, based on blood test results at the final screening visit.
• People with kidney insufficiency (reduced kidney function).
• People with an underactive thyroid that is untreated or not adequately treated, based on a specific blood test result at the final screening visit.
• People with poorly controlled type 2 diabetes, defined by a blood sugar control measure (HbA1c) above 9%.
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis.
• People who currently smoke an average of 5 or more cigarettes (or the equivalent) per day over the past year.
• People who have any other medical condition or situation that the trial doctor believes would make participation unsuitable.

Important: Always verify eligibility with the trial site directly before applying.