Novo Nordisk Investigational Site
Mainz, 55116, Germany
NCT Number: NCT04152915
The study will look at how two 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 participants get 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 medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the 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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Mainz, 55116, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
hours*nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
nmol/L
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
hours*nmol/L
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
hours*nmol/L
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
hours
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
hours
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
hours
Novo Nordisk A/S
Industry
A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector
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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