The Effect of Semaglutide on Pituitary Function

Healthy Clinical Trial

Official title:

The Effect of Semaglutide on Pituitary Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865744
• Other study ID #: Sema21
• Status: Completed
• Phase: Phase 4
• Start date: May 19, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2023
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50 years

• The body weight >65 kg

Exclusion Criteria:

• presence of chronic illness

• the daily use of medications

• pregnancy

• lactation.

Related Conditions & MeSH terms

• Healthy
• Pituitary Diseases

Intervention

Drug:
• Semaglutide 7 MG Oral Tablet
Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
• Placebo
Placebo tablet is taken after an overnight fast with up to120 ml of water.
• Semaglutide 14 MG Oral Tablet
Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Heart rate	The change in heart rate compared to baseline	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Other	Blood pressure	The change in blood pressure compared to baseline	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Primary	Growth hormone peak	Maximum concentration measured after study medication administration.	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	Cortisol peak	Maximum concentration measured after study medication administration.	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	Adrenocorticotropin (ACTH) peak	Maximum concentration measured after study medication administration.	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	Aldosterone peak	Maximum concentration measured after study medication administration.	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	Glucose nadir	Lowest glucose concentration measured after study medication administration	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	C-peptide peak	Maximum concentration measured after study medication administration.	60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary	Copeptin peak	Maximum concentration measured after study medication administration	60, 90, 120, 150, 180 and 240 minutes after study medication administration