A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

Sponsor
Novo Nordisk A/S
Study ID
NCT04152915
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks

Study Details

The study will look at how two 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 participants get 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 medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic 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. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Key Dates

Start date
Nov 25, 2019
Status verified
Nov 2021
Primary completion
May 25, 2020
Completion
May 25, 2020

Study Design

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

Arms

  • Experimental: DV3396
    Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation)
  • Experimental: PDS290
    Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation)

Primary Outcome Measure

AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period [ Time Frame: 0-840 hours after one dose of s.c. semaglutide 1 mg ]

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