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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Overweight

Healthy Volunteers

Obesity

Treatments

Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04228354

NN9536-4649

2019-004020-37 (Registry Identifier)

U1111-1241-6257 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.