The Effect of Semaglutide on Pituitary Function

The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Semaglutide 7 MG Oral Tablet; Drug: Placebo; Drug: Semaglutide 14 MG Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 51004
    • Tartu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-50 years
• The body weight >65 kg

Exclusion Criteria:

• presence of chronic illness
• the daily use of medications
• pregnancy
• lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Tartu
• Investigators: Principal Investigator: Vallo Volke, MD, PhD, University of Tartu

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases
• Other Study ID Numbers: Sema21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No