A Phase 1 interventional study of Semaglutide B, 1.34 mg/mL and Semaglutide B, 0.68 mg/mL in Diabetes Mellitus, Type 2 and Healthy Participants, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 20 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
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Exclusion Criteria:
Abuse or intake of alcohol, defined as any of the below:
Abuse or intake of drugs, defined as any of the below:
Participants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.
Drug: Semaglutide B, 1.34 mg/mL · Drug: Semaglutide B, 0.68 mg/mL
Participants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2.
Drug: Semaglutide B, 1.34 mg/mL · Drug: Semaglutide B, 0.68 mg/mL
Drug page: Semaglutide
Participants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Participants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.
AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg
Measured in hours\*nanomoles per liter (h\*nmol/L).
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
Measured in nanomoles per liter (nmol/L).
Time frame: 0-840 hours after a single dose of s.c. semaglutide 0.5 mg
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in May 2023, 4 months.
Of 393 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 4 months is below that.
Counting every sponsor, half of 458 studies reached it within 7 months; a quarter within 2 and three quarters within 14.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide