Novo Nordisk Investigational Site
Berlin, 10117, Germany
NCT Number: NCT04238962
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Berlin, 10117, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks
Increasing doses of semaglutide given sc in the stomach for 7 weeks
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
h*nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
h*nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
h
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
h
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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