Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05144984 | A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes | PHASE2 | COMPLETED | 500 | — | — | Nov 29, 2021 | Mar 23, 2023 | Apr 9, 2026 | 129 | United States, Bulgaria +7 |
| NCT05498610 | A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men | PHASE1 | COMPLETED | 24 | — | — | Aug 11, 2022 | Oct 12, 2022 | Dec 26, 2023 | 1 | China |
| NCT05015894 | A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function | PHASE1 | COMPLETED | 42 | — | — | Aug 30, 2021 | Aug 2, 2022 | Nov 13, 2023 | 1 | Germany |
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
| 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 |
| 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 |
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...