Drugs / IcoSema
last change Jul 2025 re-read 9 days ago

IcoSema

also known as NNC0148-0287sema

Other / unclassified

Developed for
type 2 diabetes mellitus
Investigated by
Novo Nordisk A/S

Trials 4

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05435677 Jun 2022 → Apr 2023 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT03789578 Jan → Oct 2019 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 32 trials · 1 met primary
Phase 3 NCT06269107 Feb 2024 → May 2025 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 3 NCT05352815 Jun 2022 → Mar 2024 type 2 diabetes mellitus Novo Nordisk A/S Completed Met primary

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2024-01-08 Novo Nordisk A/S Results COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as IcoSema “IcoSema is being developed as a subcutaneous once-weekly fixed-ratio combination of the once-weekly basal insulin icodec and the once-weekly glucagon-like peptide-1 receptor...” PMID 39488821 ↗ Nov 2024
3

NCT05435677 ↗

NCT06269107 ↗

NCT05352815 ↗

Known as NNC0148-0287sema “Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).” NCT03789578 ↗
Modality Other / unclassified “IcoSema is a once‑weekly combination therapy of basal insulin icodec [icodec] and semaglutide (a GLP‑1 analogue) currently in development.” PMID 40482671 ↗ Jun 2025
Route Subcutaneous “Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.” NCT05352815 ↗