NCT04228354

A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 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
• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks

Timeline

• Start date: 2020-01-29
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2020-01-14
• Last updated: 2022-01-10

Locations

1 site across 1 country: Germany