Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0480-0389 · 5 trials · 5 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
Count of events
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 |
| 1.7 mg NNC0480-0389 + 0.5 mg Semaglutide | EXPERIMENTAL | Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
| Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide) | PLACEBO_COMPARATOR | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
| 8.6 mg NNC0480-0389 + 0.5 mg Semaglutide | EXPERIMENTAL | Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
| Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide) | PLACEBO_COMPARATOR | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
| 30 mg NNC0480-0389 + 0.5 mg Semaglutide | EXPERIMENTAL | Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections. |
| Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide) | PLACEBO_COMPARATOR | Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection. |
| 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 | A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days. |
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 being studied for the treatment of type 2 diabetes mellitus and in healthy volunteers. It is being developed by Novo Nordisk A/S (NVO) and is currently in Phase 2 clinical development. The drug has been evaluated in combination with semaglutide in people with type 2 diabetes.
NNC0480-0389 is a small molecule developed by Novo Nordisk. Its specific molecular target has not been disclosed. Clinical trials are investigating its use alone and in combination with semaglutide for type 2 diabetes and related conditions.
NNC0480-0389 is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The drug is an investigational small molecule in Phase 2 clinical development for type 2 diabetes mellitus.
NNC0480-0389 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three clinical trials have been completed, including one Phase 2 study and several Phase 1 studies.
NNC0480-0389 has completed three clinical trials. NCT04259801 was a Phase 1 study in healthy volunteers and people with overweight, obesity, or type 2 diabetes. NCT05015894 was a Phase 1 study in participants with reduced kidney function. NCT05144984 was a Phase 2 study of semaglutide and NNC0480-0389 in type 2 diabetes. NCT05498610 was a Phase 1 study in healthy Chinese men.
No, NNC0480-0389 is not the same as semaglutide. They are separate medicines being studied together in clinical trials. NNC0480-0389 is an investigational small molecule, while semaglutide is a separate medication. Their combination is being evaluated for type 2 diabetes treatment.