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The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.
The randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers.
5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. The study group and order of administration of study medication are decided on randomization. The placebo and oral semaglutide are administered at least 4 weeks apart.
Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).
The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral semaglutide 7 mg | Active Comparator | The semaglutide 7 mg tablet taken orally with upto120 ml of water. |
|
| Placebo | Placebo Comparator | The placebo tablet taken orally with 120 ml of water. |
|
| Oral semaglutide 14 mg | Active Comparator | The semaglutide 14 mg tablet taken with upto 120 ml of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 7 MG Oral Tablet | Drug | Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth hormone peak | Maximum concentration measured after study medication administration. | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol peak | Maximum concentration measured after study medication administration. | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Adrenocorticotropin (ACTH) peak |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea. | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Heart rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vallo Volke, MD, PhD | University of Tartu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Tartu | 51004 | Estonia |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Blinded Randomised Single-group Crossover
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| Placebo | Drug | Placebo tablet is taken after an overnight fast with up to120 ml of water. |
|
| Semaglutide 14 MG Oral Tablet | Drug | Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water. |
|
|
Maximum concentration measured after study medication administration.
| 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Aldosterone peak | Maximum concentration measured after study medication administration. | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Glucose nadir | Lowest glucose concentration measured after study medication administration | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| C-peptide peak | Maximum concentration measured after study medication administration. | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Copeptin peak | Maximum concentration measured after study medication administration | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
The change in heart rate compared to baseline
| 60, 90, 120, 150, 180 and 240 minutes after study medication administration |
| Blood pressure | The change in blood pressure compared to baseline | 60, 90, 120, 150, 180 and 240 minutes after study medication administration |