NCT04238962

A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens

A Trial to Demonstrate Bioequivalence Between the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (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 2 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 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 medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit 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. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if 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-injector)	Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks
DRUG	Semaglutide (administered by PDS290 pen-injector)	Increasing doses of semaglutide given sc in the stomach for 7 weeks

Timeline

• Start date: 2020-02-03
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2020-01-23
• Last updated: 2020-11-20

Locations

1 site across 1 country: Germany