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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003216-25 | EudraCT Number | ||
| U1111-1266-4076 | Other Identifier | World Health Organization (WHO) |
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In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mL | Experimental |
| |
| Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mL | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide B, 1.34 mg/mL | Drug | Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg | Measured in h*nmol/L | 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 s.c. semaglutide 0.5 mg administration | Measured in nmol/L | 0-840 hours after a single dose of s.c. semaglutide 0.5 mg |
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Inclusion Criteria:
Exclusion Criteria:
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening
Abuse or intake of alcohol, defined as any of the below:
Abuse or intake of drugs, defined as any of the below:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel CPRU, Level 7 | Harrow | Middlesex | HA1 3UJ | United Kingdom |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Semaglutide D, 1.0 mg/mL | Drug | Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously. |
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| Semaglutide D, 1.0 mg/mL | Drug | Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously. |
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| Semaglutide B, 1.34 mg/mL | Drug | Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously. |
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