A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT04012255
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

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. 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 stomach with the use of 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 themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total 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
Jul 15, 2019
Status verified
Oct 2019
Primary completion
Aug 30, 2019
Completion
Oct 22, 2019

Study Design

Enrollment
29 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

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

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