Novo Nordisk opens CagriSema trial in children and teens with type 2 diabetes
Novo Nordisk has started enrolling children and adolescents with type 2 diabetes in a placebo-controlled Phase 3 trial of CagriSema, a combination that is not yet approved in any age group.
A Novo Nordisk Phase 3 trial of CagriSema in children and adolescents with type 2 diabetes has started recruiting, according to a trial-status change recorded on Sept. 9, 2026 [1].
The study is listed in the federal registry as NCT07282613, under the title "A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes" [1]. Its status moved from "not yet recruiting" to "recruiting" [1]. CagriSema is a combination of cagrilintide and semaglutide, the active ingredient in Wegovy [2].
The change record does not list an enrollment target, a start date or a completion date for the pediatric study [1]. How many children and adolescents will take part, how long they will be followed, and what background diabetes treatment they will receive alongside the study drug have not been reported [1].
CagriSema remains experimental in every age group. A regulatory decision on the combination is expected in the fourth quarter of 2026, and Novo Nordisk is also expected to report results from a maintenance-dose study of the treatment [2]. Two other CagriSema studies have moved recently. A Phase 3 study of switching adults with type 2 diabetes from semaglutide to CagriSema was newly registered and is not yet recruiting, with a planned 210 participants [1]. A Phase 2 study of CagriSema against placebo in adults with type 2 diabetes and painful diabetic peripheral neuropathy changed to completed, with its results date moved about two months earlier, to June 26, 2026 [1].
Other companies are also moving into younger patients. Eli Lilly registered a Phase 3 trial of tirzepatide in children ages 6 to under 12 who have obesity, called ADVANCE-SURMOUNT-KIDS, with a planned 150 participants and a status of not yet recruiting [1]. Tirzepatide is sold as Mounjaro and Zepbound [2]. That study targets obesity, not type 2 diabetes.
Why it matters for patients
No results from CagriSema in children or adolescents have been reported, so nothing is known yet about how the combination affects blood sugar or body weight in that age group, or how well it is tolerated [1]. The trial is placebo-controlled, meaning some participants will receive a placebo rather than the study drug [1].
CagriSema itself is not yet approved for adults, with a regulatory decision expected in the fourth quarter of 2026 [2]. Any pediatric use would therefore come later than adult use, though no timeline for a pediatric filing or approval has been disclosed [1][2].
Pediatric trials typically take years, and the registry record for this study does not state when it is expected to finish or when results might be available [1]. Families weighing a clinical trial against currently available options would need details that the record does not yet contain.
What happens next
- Fourth quarter of 2026: a regulatory decision on CagriSema is expected, and Novo Nordisk is expected to report results from a maintenance-dose study of the combination [2].
- By the end of 2026: Novo is scheduled to begin late-stage trials of its oral obesity drug zenagamtide and of high-dose cagrilintide, according to the investment bank William Blair [2].
- Sept. 28 to Oct. 2, 2026: AstraZeneca is expected to present data on AZD6234, an amylin receptor agonist, at the European Association for the Study of Diabetes annual meeting in Italy [2].
- The pediatric CagriSema trial is now recruiting; enrollment targets and completion dates have not been reported [1].
Sources
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