US-ENG
US-ENG
The Transcend Study is evaluating the safety and efficacy of an investigational medicine (setmelanotide) in participants with acquired Hypothalamic obesity (HO).
An investigational medicine is being evaluated for the potential treatment of acquired Hypothalamic obesity or HO and hyperphagia. It’s being compared to a placebo, which looks like the investigational medicine but has no active ingredients. Neither you nor the study team will know which you are receiving.
There will be about 15-17 visits during the study treatment period. Be sure to complete all scheduled study visits, in person or remotely. Please inform the study staff immediately if you need to reschedule a visit.
You will receive the investigational medicine to administer every morning at home. It must be stored in a refrigerator. Once opened, the medicine may be stored at room temperature for up to 30 days. On the day of your scheduled visits, you should wait to administer the medicine until you are at the study clinic. The study staff will make sure you are administering the medicine correctly.
You are being asked to participate in this study for at least one year. Participants who complete the 60-week treatment period may have the option to enroll in a long-term extension study. In the long-term extension study, all participants will receive setmelanotide.
If you experience any adverse events, side effects, or simply have a question; please feel free to reach out to your study team.
