NCT04152915

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

A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers
• Diabetes Mellitus, Type 2

Interventions

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

Timeline

• Start date: 2019-11-25
• Primary completion: 2020-05-25
• Completion: 2020-05-25
• First posted: 2019-11-05
• Last updated: 2021-11-10

Locations

1 site across 1 country: Germany