The Effect of Semaglutide on Pituitary Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Semaglutide on Pituitary Function

Conditions
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Healthy

Intervention / Treatment
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* Drug: Semaglutide 7 MG Oral Tablet
* Drug: Placebo
* Drug: Semaglutide 14 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 years The body weight >65 kg Exclusion Criteria: presence of chronic illness the daily use of medications pregnancy lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Blinded Randomised Single-group Crossover
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral semaglutide 7 mg<br>The semaglutide 7 mg tablet taken orally with upto120 ml of water. | Drug: Semaglutide 7 MG Oral Tablet<br>* Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.<br>* Other names: Rybelsus 7 mg;|
| Placebo Comparator: Placebo<br>The placebo tablet taken orally with 120 ml of water. | Drug: Placebo<br>* Placebo tablet is taken after an overnight fast with up to120 ml of water.<br>|
| Active Comparator: Oral semaglutide 14 mg<br>The semaglutide 14 mg tablet taken with upto 120 ml of water. | Drug: Semaglutide 14 MG Oral Tablet<br>* Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.<br>* Other names: Rybelsus 14 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |