Cagrilintide and CagriSema trial registration in children and adolescents with excess body weight

This is a trial registration in humans — specifically children and adolescents with excess body weight — and the source text does not state how many participants are planned or enrolled. The registration states the study will look at how well CagriSema and cagrilintide help this group lose weight.

The record describes two parts, a main study and an extension study. In the main part, participants receive CagriSema, cagrilintide, semaglutide or placebo, and the registration states that which treatment participants get is decided by chance. Participants assigned semaglutide in the main study do not continue into the extension study; those who do continue receive either CagriSema or cagrilintide.

Because this is a registration rather than a results publication, the source text reports no outcome data. It describes planned duration: about 1 year and 6 months total in the main study, and about 4 years and 10 months total for participants who also take part in the extension study.

The registration notes that, like all drugs, the study drugs may have side effects, but it does not list specific adverse events or rates in the provided text.

No milligram amounts appear in the source text. The registration states that participants in the CagriSema arm receive a once weekly subcutaneous dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks, maintained for 52 weeks, continuing at the same dose or maximum tolerated dose in the open-label extension phase for up to 156 weeks.

Participants in the cagrilintide arm receive a once weekly subcutaneous dose in a dose escalation regimen for up to 16 weeks, maintained for 52 weeks, with the same dose or maximum tolerated dose in the extension for up to 156 weeks. Participants in the semaglutide arm receive a once weekly subcutaneous dose escalated over up to 16 weeks and maintained for 52 weeks. Placebo participants receive a once weekly subcutaneous dose matched to cagrilintide/semaglutide on the same schedule.

This is a registration-only record: no results, no effect sizes and no safety counts are reported in the source text. The number of participants, the study phase, the recruitment status and the study sites are not stated in the provided text, so nothing can be said about statistical power or generalizability.

The source text also does not specify doses in milligrams, eligibility criteria such as age range or body-mass thresholds, outcome measures, or who sponsors or funds the study. The description is written in plain-language summary form, which omits methodological detail that a full study protocol would contain.

Per this site's regulatory review, cagrilintide, studied alone and coformulated with semaglutide as CagriSema, is not an FDA-approved drug for any use. The registration itself notes that semaglutide is a drug that doctors can already prescribe to adolescents and adults.