Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Co-formulation NNC0480 0389+Semaglutide A 10/mL · 1 trial · 1 indication
h\*nmol/L
h\*nmol/L
| Arm | Type | Description |
|---|---|---|
| NNC0480-0389 + semaglutide(co-formulation)and placebo | EXPERIMENTAL | Sequence A: The participants will be administered a single subcutanous (s.c.) dose of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as a co-formulation by a single injection and a placebo injection |
| NNC0480-0389 + semaglutide (separate injections) | ACTIVE_COMPARATOR | Sequence B: The participants will be administered 0.5 mg semaglutide and 5 mg NNC0480 0389 as an subcutaneus injection (s.c) on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as two separate injections. |
| Name | Type | Description |
|---|---|---|
| Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL | DRUG | Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks. |
| semaglutide 1.34 mg/mL (placebo) | DRUG | Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks. |
| Semaglutide 1.34 mg/mL | DRUG | The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks. |
| NNC0480-0389 A 10 mg/mL | DRUG | The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks. |
Inclusion Criteria: * Male or female of non-childbearing potential (NCBP), aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive). Exclusion Criteria: * Any disorder which in the investigator's opinion migh...
Co-formulation NNC0480 0389+Semaglutide A 10/mL is an investigational injectable combination product being developed by Novo Nordisk for type 2 diabetes. It combines semaglutide with the small molecule NNC0480-0389 in a single co-formulated injection, and it has been studied in a Phase 1 trial in healthy volunteers.
It is being developed for the treatment of type 2 diabetes mellitus. The Phase 1 study of this co-formulation enrolled healthy volunteers rather than patients with type 2 diabetes, and it examined blood levels of semaglutide and NNC0480-0389 when the two components were given together in one injection.
Novo Nordisk A/S, which trades under the ticker NVO, is the developer of Co-formulation NNC0480 0389+Semaglutide A 10/mL. The company sponsored the Phase 1 study of the combination, which was conducted in Germany.
Co-formulation NNC0480 0389+Semaglutide A 10/mL is in Phase 1 development. One Phase 1 trial has been completed, and no trials of this co-formulation are currently active. It is an investigational product and has not been approved by the FDA.
The co-formulation has been evaluated in one completed Phase 1 trial, NCT05046873, titled a research study looking into blood levels of semaglutide and NNC0480-0389 when given in the same injection or in two separate injections in healthy people. It was a randomized, double-blind, active-controlled study that enrolled 16 participants in Germany.