You will be required to commit your time to this study. This is important for the study and we greatly appreciate and encourage patient feedback.
Step 1: Screening Visit
You will visit our clinic for some routine checks like blood pressure, weight, and height measurements. We will also take some blood tests. You will meet with our team to share some details about yourself, your current medications, and any health conditions you have. We will book you a 24 hour blood pressure monitor if you have not had one recently.
Step 2: Run-in Period (4 weeks)
During this time, we'll keep an eye on your blood pressure, but you won't need to make any changes to your current treatment. We might ask you to measure your blood pressure at home a few times a day, but it's easy, and we will guide you through it. We will also ask you to answer some questions about you, your health and medicines in a number of questionnaires.
Step 3: Randomisation Visit
At this visit, we will check measurements to see if you are suitable to continue to the next stage. If you are, we will then either start you on the trial drug, semaglutide (Ozempic® or Wegovy®), or the placebo and will continue with your current management plan. Placebo refers to an injection with an empty medical syringe with a sterile needle attached. No product or air will be injected. The Placebo will produce the same sound and feel as the trial drug upon administration. You will have a 50% chance of being on the trial drug and the remaining 50% chance of being on the Placebo. The drug or placebo will be administered on at least 36 occasions. This decision will be made randomly by a computer. We will give you some tips on how to live a healthier life. Nothing complicated, just simple advice to keep you feeling your best.
Step 4: Follow-up Assessments (Every 12 weeks)
Every 12 weeks, we'll check in with you either at home or in person. We'll remind you beforehand and ask for your blood pressure readings and weight (every day for one week and your weight at the end of the week). It's quick and easy, and it helps us keep track of how you're doing.
Step 5: Final Visit
After about nine months, we'll do some final checks to see how you've been doing. We'll measure your blood pressure, weight, and take some blood tests. It's just like your screening visit, but this time, we're wrapping things up!
What's Next?
If you choose, you can continue to share your data with us every 12 weeks. We'll let you know what's happening next based on how the trial goes.
If Things Change
If, for any reason, you need to leave the trial early, don't worry. We'll make sure everything is completed for you, and we'll still be here to help you if you need it.
Throughout Your Journey
Your safety is our top priority. If you ever have any concerns or experience anything unusual, let us know. We're here to help you every step of the way.