Study S001767

A Study to Investigate the Pharmacokinetics of Semaglutide and NNC0480-0389 When Subcutaneously Administered as a Co-formulation or as Separate Injections in Healthy Participants

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05046873
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 16
Start: 2021-09-06
Primary completion: 2022-01-05
Lead sponsor: Novo Nordisk A/S
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
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1266-0502; EUDRACT_NUMBER:2021-001397-36

Registered primary outcomes

AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose [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 [From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)]

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