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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
10
Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
Placebo tablet is taken after an overnight fast with up to120 ml of water.
Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.
Tartu University Hospital
Tartu, Estonia
Growth hormone peak
Maximum concentration measured after study medication administration.
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Cortisol peak
Maximum concentration measured after study medication administration.
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Adrenocorticotropin (ACTH) peak
Maximum concentration measured after study medication administration.
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Aldosterone peak
Maximum concentration measured after study medication administration.
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Glucose nadir
Lowest glucose concentration measured after study medication administration
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
C-peptide peak
Maximum concentration measured after study medication administration.
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Copeptin peak
Maximum concentration measured after study medication administration
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
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