F03425 – Cholesterol Lowering Trial
This clinical study is exploring whether combining an investigational medicine called enlicitide with the commonly used cholesterol lowering drug rosuvastatin can further reduce LDL-C (bad cholesterol) beyond what is usually achieved with standard statin therapy alone. Participants will receive one tablet and one capsule of both study drugs, either study drug with placebo, or two lots of placebo by mouth daily and attend regular study visits to monitor cholesterol levels, overall health and safety.
The study involves a screening period, a 12-week double-blind treatment phase and a follow-up period. During the trial, participants will need to follow fasting instructions, maintain a stable diet and exercise routine and avoid certain medications that could interfere with cholesterol-lowering treatment.
All study medication, medical assessments and tests are provided at no cost. Participants will be reimbursed for their time and travel.
Eligibility requirements
- Age: 18-64
- Sex: M & F
- Medication: To take part, you’ll need to avoid non-study cholesterol-lowering medicines during the trial. Some medicines that interact with rosuvastatin are also not allowed. You’ll take the study medicines first thing in the morning after an overnight fast (no food/drink except small amounts of water for ≥8 hours), then wait 30 minutes before eating or drinking anything other than water.
- Medical History: You may not be able to join if you: have statin intolerance or major muscle disorders; active liver disease or abnormal liver tests; severe kidney disease; IBS or other bowel conditions which may affect absorption.
Outpatient Visits
- Approximately 8 visits over 28 weeks, including the 2 screening visits.
Payment/Remuneration
- You will be reimbursed for your time of $180 for the initial screening visit, then $230 per following clinic visits, and $35 for a telephone call at week 20.
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.