NCT04012255

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

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulations With the DV3396 Pen-injector and With the PDS290 Pen-injector in Subjects With Overweight or Obesity

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide (administered by DV3396 pen)	Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
DRUG	Semaglutide (administered by PDS290 pen)	Increasing doses of semaglutide given sc in the stomach for 21 weeks

Timeline

• Start date: 2019-07-15
• Primary completion: 2019-08-30
• Completion: 2019-10-22
• First posted: 2019-07-09
• Last updated: 2019-10-23

Locations

2 sites across 1 country: Germany