F03525 – Heart & Kidney Health Trial
This clinical study is exploring whether an investigational oral medicine can help reduce the risk of major cardiovascular and kidney events in adults living with atherosclerotic cardiovascular disease (ACD) and/or chronic kidney disease (CKD) in comparison to placebo. Participants will receive one tablet by mouth daily and attend regular study visits. The research team will monitor heart and kidney health.
The study includes a screening period, a long-term treatment phase and a follow-up period. Throughout the trial, participants will be asked to follow study dosing instructions, keep their usual diet and activity level stable. Also, participants will be asked to avoid certain medications that could interfere with the study treatment or affect safety assessments.
All study medication, clinic visits, medical assessments and laboratory tests are provided at no cost and participants will be reimbursed for their time and travel.
Eligibility requirements
- Age: 50+
- Sex: M & F
- BMI: Must be 25.0 or above
- Medication: To take part, you must not be using medications that are prohibited in the study, including GLP-1-based therapies, pramlintide or strong CYP3A inducers or inhibitors. The study team will review your current medicines to ensure there are no interactions that would prevent participation. You’ll take the study medication once daily in the morning, following the dosing instructions provided by the research team. You may also be asked to follow timing or food-related guidelines to ensure accurate and consistent study assessments.
- Medical History: You may not be able to join if you have certain medical conditions that could affect your safety in the study, including: significant liver disease or abnormal liver test results, severe kidney impairment outside the study’s eligibility criteria, gastrointestinal conditions that may affect medication absorption, or other health issues that the study doctor determines make participation unsafe.
Outpatient Visits
- You'll attend a series of scheduled outpatient visits during screening, throughout the long-term treatment phase and during follow-up, with some check-ins completed by phone or remotely when appropriate. This is likely to be a minimum of 15 visits over 3.5+ years.
Payment/Remuneration
- You'll receive reimbursement for your time and travel of $75 per visit.
How to apply
To register your interest in this trial, please complete the form below, or call us on 1800-FUSION (1800 387 466). A Fusion team member will be in contact to discuss your eligibility shortly.