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Clinical Trial Details

Trial ID: L2388
Source ID: NCT05363774
Associated Drug: Nnc0519-0130
Title: A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Volunteers (Diabetes Mellitus, Type 2)
Interventions: DRUG: NNC0519-0130|DRUG: Placebo (NNC0519-0130)
Outcome Measures: Primary: Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part, Measured as Number of events, From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)|Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort, Measured as Number of events, From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)|Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort, Measured as Number of events, From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)|Number of treatment emergent adverse events (TEAE) in T2D QW cohort, Measured as number of events, From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days) | Secondary: AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose, Measured in h\*nmol/L, From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)|Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose, Measure in nmol/L, From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)|Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort, Measured as Number of events, From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days)|AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part, Measured in h\*nmol/L, From pre-dose (last dose in each treatment period) until 24 hours post-dose|Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part, Measured in nmol/L, From pre-dose (last dose in each treatment period) until 24 hours postdose|AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort, Measured in h\*nmol/L, From pre-dose (last dose) until 168 hours post-dose|Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort, Measured in nmol/L, From pre-dose (last dose) until 168 hours post-dose|AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort, measured in h\*nmol/L, From pre-dose (last dose in each treatment period) until 168 hours post-dose|Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort, Measured in nmol/L, From pre-dose (last dose in each treatment period) until 168 hours post-dose
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 161
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-04-20
Completion Date: 2024-04-02
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Novo Nordisk Investigational Site, Søborg, 2860, Denmark|Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT05363774