A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Overweight

Obesity

Treatments

Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04187300

2019-002909-21 (Registry Identifier)

U1111-1236-7697 (Other Identifier)

NN9536-4590

Details and patient eligibility

About

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, but it has been approved as a treatment for diabetes mellitus. 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 belly using 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 the medicine. Participants will take an injection once a week and will get a total of 21 injections 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.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Inability or unwillingness to perform self-injection