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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05046873 | 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 | PHASE1 | COMPLETED | 16 | — | — | Sep 6, 2021 | Jan 5, 2022 | Jul 3, 2023 | 1 | Germany |
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...