Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0480-0389 · 4 trials · 4 indications
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
measured in hnmol\^L
measured in nmol/L
h\*nmol/L
Number of events
Number of events
| Arm | Type | Description |
|---|---|---|
| 2.4 mg semaglutide + 2.4 mg NNC0480-0389 | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide. |
| Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389) | PLACEBO_COMPARATOR | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide). |
| 2.4 mg semaglutide + 7.2 mg NNC0480-0389 | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide |
| 2.4 mg semaglutide + 12.0 mg NNC0480-0389 | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide |
| 2.4 mg semaglutide + 21.6 mg NNC0480-0389 | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide |
| NNC0480-0389 + placebo (semaglutide) | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide) |
| Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389) | PLACEBO_COMPARATOR | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide). |
| Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389) | PLACEBO_COMPARATOR | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide). |
| Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389) | PLACEBO_COMPARATOR | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide). |
| Semaglutide 2.4 mg + placebo (NNC0480-0389) | EXPERIMENTAL | subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide. |
| 1.7 mg NNC0408-0389 plus 0.5 mg semaglutide | EXPERIMENTAL | Participants will receive a single subcutanous dose of 1.7 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
| 8.6 mg NNC0480-0389 plus 0.5 mg semaglutide | EXPERIMENTAL | Participants will receive a single subcutanous dose of 8.6 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
| 30 mg NNC0480 0389 plus 0.5 mg semaglutide | EXPERIMENTAL | Participants will receive a single subcutanous dose of 30 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections |
| NNC0480-0389 | EXPERIMENTAL | All participants will be administered a single s.c. dose of 18 mg NNC0480-0389 |
| NNC0480-0389 and semaglutide | EXPERIMENTAL | Part 1: 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide. Part 2: 12 subjects will receive 4 doses of s.c. NNC0480-0389 co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c semaglutide. |
| NNC0480-0389 and placebo (semaglutide) | EXPERIMENTAL | Part 1: 4 subjects will receive a single dose of s.c. NNC0480-0389 co-administered with semaglutide placebo. Part 2: 4 subjects will receive 4 doses of s.c. NNC0480-0389, co-administered with semaglutide placebo after 8 weeks of dosing with semaglutide placebo. |
| Placebo (NNC0480-0389) with semaglutide | ACTIVE_COMPARATOR | Part 1: 2 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with s.c. semaglutide. Part 2: 4 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c. semaglutide |
| Placebo (NNC0480-0389) with placebo (semaglutide) | PLACEBO_COMPARATOR | Part 1: 3 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with semaglutide placebo. Part 2: 2 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with semaglutide placebo, after 8 weeks of dosing with semaglutide placebo. |
| Name | Type | Description |
|---|---|---|
| NNC0480-0389 | DRUG | A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks. |
| Semaglutide | DRUG | A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks. |
| Placebo (NNC080-0389) | DRUG | A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks. |
| Placebo (semaglutide) | DRUG | A weekly dose of placebo (semaglutide). The study will last for about 41weeks. |
| NNC0480 0389 | DRUG | Participants will get 1 injections of NNC04800389. It will be injected with a needle into a skin fold on the abdomen. The study will last for a maximum of 72 days |
| Placebo (NNC0480-0389) | DRUG | Placebo for NNC0480-0389. Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort. |
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations g...
NNC0480-0389 is an investigational small molecule developed by Novo Nordisk A/S for metabolic conditions. It has been studied in type 2 diabetes and overweight, and in clinical trials it was given in combination with semaglutide. It is a Phase 2 candidate and is not approved for any use.
NNC0480-0389 has been studied as a treatment for type 2 diabetes, including in combination with semaglutide. Trials have also enrolled people who are overweight or have obesity. It remains investigational and is not approved for prescribing in type 2 diabetes or any other indication.
NNC0480-0389 is developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. The company sponsored the clinical studies of the compound, including a Phase 2 trial in type 2 diabetes and several Phase 1 trials.
NNC0480-0389 has reached Phase 2 clinical development. Its Phase 2 trial in type 2 diabetes has been completed, and the Phase 1 studies have also been completed. The drug is investigational and has not been approved by the FDA or any other regulator.
NNC0480-0389 has been evaluated in completed trials including NCT05144984, a Phase 2 study of the combination with semaglutide in type 2 diabetes, and Phase 1 studies NCT05498610, NCT05015894, and NCT04259801. These studies covered type 2 diabetes, overweight, obesity, and healthy volunteers.
Yes. NNC0480-0389, NNC0480 0389, NNC0480-0389 10 mg/mL, and NNC0480-0389/mL all refer to the same investigational Novo Nordisk compound. The different forms reflect how the drug name and its concentration are written in study documentation.