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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1147-6660 | Other Identifier | WHO | |
| JapicCTI-142550 | Registry Identifier | JAPIC |
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This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 0.5 mg | Experimental | Dose-escalation trial |
|
| Semaglutide placebo 0.5 mg | Placebo Comparator |
| |
| Semaglutide 1.0 mg | Experimental | Dose-escalation trial |
|
| Semaglutide placebo 1.0 mg | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma semaglutide concentration-time curve | During a dosing interval (0-168 hours) at steady state |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma semaglutide concentration at steady state | 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg) | |
| Change in body weight from baseline to the end of treatment | Day 1 of Visit 2 (2-21 days after Visit 1), Day 92 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tokyo | 130-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29536338 | Result | Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Apr;35(4):531-544. doi: 10.1007/s12325-018-0677-1. Epub 2018 Mar 13. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| placebo | Drug | Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule. |
|
| Number of treatment emergent adverse events (TEAEs) from baseline to follow-up | From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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