Study S000110

A Trial to Demonstrate Bioequivalence Between the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide

ClinicalTrials.gov record

Registration

Registration: NCT04238962
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 111
Start: 2020-02-03
Primary completion: 2020-10-20
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:Semaglutide (administered by DV3396 pen-injector); DRUG:Semaglutide (administered by PDS290 pen-injector)
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1239-1473; REGISTRY:2019-003477-25; NIH:2019

Registered primary outcomes

AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period [0-840 hours after one dose of s.c. semaglutide 2 mg]
Cmax,sema,2mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period [0-840 hours after one dose of s.c. semaglutide 2 mg]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.