A Study of Brenipatide in Participants With Opioid Use Disorder

To join this study, you need to be aged between 18 and 75 years old and have been diagnosed with opioid use disorder. You should be someone who can reliably attend all study appointments and follow instructions, including taking your study medicine and keeping a diary. It's also important that you are currently using non-prescription opioids sometimes and are already taking buprenorphine for your opioid use disorder.

There are also some reasons why you might not be able to join. For example, if you have certain other substance use disorders, like a more serious alcohol or cannabis use problem within the last six months (tobacco and small amounts of alcohol/cannabis are usually okay). You also can't join if you’ve had a severe opioid overdose in the past six months, or if you have certain serious health conditions like advanced liver disease, some mental health conditions (like schizophrenia or bipolar disorder), or severe diabetes.

Finally, if you've been in another medical study recently where you received treatment, you might need to wait a certain amount of time before you can join this one. The study team will review all these details carefully with you to decide if this study is suitable and safe for you.

If you decide to take part in this study, you'll be assigned to one of two main groups. In one group (Part A), you'll either receive the new medicine (brenipatide) or a dummy medicine (placebo) without knowing which one, and then you might have the option to continue with brenipatide openly. In the other group (Part B), you'll know that you're receiving brenipatide. You will be in only one of these parts.

Your involvement will include regularly injecting the study medicine yourself, or having someone you trust, who has been trained, help you. You'll also need to store the medicine properly and use it exactly as instructed. Throughout the study, you'll be asked to keep a diary, either on paper or electronically, and fill out questionnaires about how you're feeling and how the medicine is working. You will have regular visits to the study clinic for check-ups and to review your progress.

The total time you might participate in the study varies. For some, it could be around 116 weeks (about 2 years and 2 months), while for others, it could be up to 144 weeks (about 2 years and 9 months). However, the exact duration depends on when you join and how quickly other people join the study. During your time in the study, you will have plenty of support and guidance from the study team.