Healthy
Conditions
Brief summary
The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.
Detailed description
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.
Interventions
DRUGSemaglutide 7 MG Oral Tablet
Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
DRUGPlacebo
Placebo tablet is taken after an overnight fast with up to120 ml of water.
DRUGSemaglutide 14 MG Oral Tablet
Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.
Sponsors
University of Tartu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Blinded Randomised Single-group Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-50 years * The body weight \>65 kg
Exclusion criteria
* presence of chronic illness * the daily use of medications * pregnancy * lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth hormone peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aldosterone peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration. |
| Glucose nadir | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Lowest glucose concentration measured after study medication administration |
| C-peptide peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration. |
| Copeptin peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration |
| Cortisol peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration. |
| Adrenocorticotropin (ACTH) peak | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | Maximum concentration measured after study medication administration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | The change in blood pressure compared to baseline |
| Nausea | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea. |
| Heart rate | 60, 90, 120, 150, 180 and 240 minutes after study medication administration | The change in heart rate compared to baseline |
Countries
Estonia
Outcome results
None listed