Clinical Research Study for Teens and Other Adolescents

About the Study

This is a research study evaluating the safety of an investigational drug as well as how it is processed in the body. Participation will include frequent clinic visits, questionnaires, physical exams, and blood tests.

• The study assessments and study drug will be provided free of charge.
• Participation is voluntary.
• Choosing not to participate will not affect your regular medical care.

What happens during the study?

For each participant, the study could last up to 3 years in total.
More frequent visits to the study center are required early on. Visits will become less frequent later on in the study. There will be around 11 in-person visits at the study center during the first 16 weeks. A study participant will receive the investigational drug 9 times during this period.

In the second part of the study, which will last about 104 weeks, there will be 15 in-person visits:

• With 14 injections at the study center
• And possibly 11 self-injections at home.
• There will be a final in-person visit at the study center 20 weeks after the last injection of the investigational drug.
• The number of injections a study participant receives each time will depend on how much the person weighs.
• The investigational drug is given by injection just under the skin (in the fatty tissue just under the outer layer).

During the first part of the study (initial study treatment phase), the investigational drug will be given to study participants by staff at the study center. During the second part of the study (open-label extension), to reduce travel time to the study center, each study participant or caregiver may choose to receive training in how to give the injections at home. Approximately half of the injections will be given by staff at the study center.

While study participants will not receive any payment for participation in this study, reimbursement for study- related travel costs may be provided. Before any decision can be made about joining the study, the study team will explain everything in more detail, including the known risks and benefits. There will also be the opportunity to ask questions.