Novo opens a pediatric CagriSema trial in type 2 diabetes
A Novo Nordisk Phase 3 trial testing CagriSema in children and teens with type 2 diabetes has begun recruiting, extending the combination drug into a group where no GLP-1/amylin therapy has yet been studied.[1]
A Novo Nordisk Phase 3 study of CagriSema in children and adolescents with type 2 diabetes has moved from "not yet recruiting" to "recruiting," according to a registry change logged on 2026-09-09.[1] The trial, titled "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," is testing the drug against placebo.[1]
CagriSema combines cagrilintide, an amylin analog, with semaglutide, the active ingredient in Wegovy and Ozempic.[2] No GLP-1/amylin combination has previously been tested in a pediatric population with type 2 diabetes, so this study extends the drug's development into age groups where labels for these medicines remain narrow.[2]
The pediatric trial opening comes as Novo pushes CagriSema forward on several fronts in adults. A US regulatory decision on CagriSema is expected in the fourth quarter of 2026.[2] Novo is also expected to report results this year from a maintenance dose study of the combination, and the company has separately registered a new Phase 3 study, not yet recruiting, comparing tolerability of switching from semaglutide to CagriSema in about 210 adults with type 2 diabetes.[1] A separate CagriSema study in adults with type 2 diabetes and painful diabetic peripheral neuropathy has moved from active-not-recruiting to completed, with its results date shifted from August 2026 to June 2026.[1]
Novo's broader 2026 pipeline includes plans to start late-stage trials of an oral obesity medication called zenagamtide and a high-dose version of cagrilintide by year's end, according to an analysis from investment bank William Blair cited by BioSpace.[2] The company currently holds about 90% of weekly oral GLP-1 prescriptions in the US through Wegovy's pill form, or roughly 1.5 million people, though it saw a revenue stumble for that product in the second quarter.[2]
Why it matters for patients
The registry status change means the pediatric trial is now open for enrollment, but it does not mean CagriSema is approved or available for children and teens with type 2 diabetes. No GLP-1/amylin combination has been evaluated in this age group before, so how the drug performs on blood sugar, weight, and safety in children remains an open question that this study is designed to answer.[2]
For adults, the more immediate milestone is the expected fourth-quarter 2026 US decision on CagriSema.[2] Families and patients tracking whether this combination might eventually reach younger patients should note that pediatric trials typically take years to complete before any regulatory filing follows, and the sources here do not give an expected completion or results date for the children's study.[1]
Patients currently on semaglutide-based products who are curious about switching to CagriSema may also be relevant to a separate, newly registered adult trial examining tolerability of that switch, though that study has not yet begun recruiting.[1]
What happens next
A US regulatory decision on CagriSema in adults with type 2 diabetes is expected in the fourth quarter of 2026.[2] Results from a maintenance dose study of CagriSema are also expected this year.[2] The pediatric trial itself is now recruiting, but no completion or results date is specified in the available sources, and it is not yet known when data from this study will be available.[1]
Sources
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