Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease

To join this study, you generally need to have diagnosed Peripheral Arterial Disease (PAD) that causes leg pain when you walk. Doctors will measure something called your Ankle Brachial Index (ABI), which compares blood pressure in your ankle and arm, and this needs to be 0.9 or less to suggest PAD.

There are also some reasons why you might not be able to join. For example, if you're very underweight (BMI less than 23) or if your long-term blood sugar levels (HbA1c) are very high (over 10%). Also, if other health problems, not just PAD, are making it hard for you to walk, or if you've recently had certain heart problems like a heart attack or stroke, you might not be suitable.

You also can't take part if you've recently had surgery on your blood vessels in your legs within the last 90 days, or if you're planning such surgery during the study. Similarly, if you have severe heart failure (classified as New York Heart Association class III or IV), this study would not be right for you. The study is open to both men and women aged 18 and over.

If you decide to take part in this study, you'll be involved for about 58 weeks, which is a bit over a year. Throughout this time, you'll regularly visit the study clinic. At these visits, doctors and nurses will assess your health, including how well you can walk and any pain you experience. You will also have various health checks and tests done to monitor your condition and how the study medicine is affecting you.

During the study, you'll be given either the new medicine, Orforglipron, or a dummy pill (placebo), to take daily. You won't know which one you're receiving, and neither will the study team in most cases. You will be closely monitored for any side effects or changes in your health. After the 58 weeks, there will be a final check-up to wrap up your participation.