The Effect of Semaglutide on Pituitary Function

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Semaglutide 7 MG Oral Tablet; Drug: Placebo; Drug: Semaglutide 14 MG Oral Tablet

• Registration Number: NCT04865744
• Lead Sponsor: University of Tartu

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.

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2021-05-19
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral semaglutide 7 mg	Semaglutide 7 MG Oral Tablet	The semaglutide 7 mg tablet taken orally with upto120 ml of water.
Placebo	Placebo	The placebo tablet taken orally with 120 ml of water.
Oral semaglutide 14 mg	Semaglutide 14 MG Oral Tablet	The semaglutide 14 mg tablet taken with upto 120 ml of water.

Primary Outcome Measures

Name	Time	Method
Growth hormone peak	60, 90, 120, 150, 180 and 240 minutes after study medication administration	Maximum concentration measured after study medication administration.

Secondary Outcome Measures

Name	Time	Method
Adrenocorticotropin (ACTH) 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
Cortisol 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
Aldosterone peak	60, 90, 120, 150, 180 and 240 minutes after study medication administration	Maximum 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.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia