A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT04187300
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Study Details

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.

Key Dates

Start date
Dec 16, 2019
Status verified
Nov 2021
Primary completion
Sep 23, 2020
Completion
Sep 23, 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 (Formulation D)
  • Experimental: PDS290
    Semaglutide administered with the PDS290 pen-injector (Formulation B)

Primary Outcome Measure

AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve [ Time Frame: 0-168 hours (Day 141-148) after last 2.4 mg dose ]

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