A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens

Sponsor
Novo Nordisk A/S
Study ID
NCT04238962
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The study will look at how 2 different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide - which version is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Key Dates

Start date
Feb 3, 2020
Status verified
Nov 2020
Primary completion
Oct 20, 2020
Completion
Oct 20, 2020

Study Design

Enrollment
111 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DV3396
    Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
  • Active Comparator: PDS290
    Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)

Primary Outcome Measure

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 [ Time Frame: 0-840 hours after one dose of s.c. semaglutide 2 mg ]

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