Clinical Trial Details
| Trial ID: | L3445 |
| Source ID: | NCT05046873 |
| Associated Drug: | Co-Formulation Nnc0480 0389+Semaglutide A 10/1 Mg/Ml |
| Title: | 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 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL|DRUG: semaglutide 1.34 mg/mL (placebo)|DRUG: Semaglutide 1.34 mg/mL|DRUG: NNC0480-0389 A 10 mg/mL |
| Outcome Measures: | Primary: AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose, h\*nmol/L, From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)|AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve after a single dose, h\*nmol/L, From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36) | Secondary: Cmax,sema,SD: Maximum plasma concentration of semaglutide after a single dose, nmol/L, From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)|Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 after a single dose, nmol/L, From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36) |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 16 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2021-09-06 |
| Completion Date: | 2022-01-05 |
| Results First Posted: | |
| Last Update Posted: | 2023-07-03 |
| Locations: | Novo Nordisk Investigational Site, Berlin, 14050, Germany |
| URL: | https://clinicaltrials.gov/show/NCT05046873 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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