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The Effect of Semaglutide on Pituitary Function

Primary Purpose

Healthy

Status
Completed
Phase
Phase 4
Locations
Estonia
Study Type
Interventional
Intervention
Semaglutide 7 MG Oral Tablet
Placebo
Semaglutide 14 MG Oral Tablet
Sponsored by
University of Tartu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tartu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Oral semaglutide 7 mg

Placebo

Oral semaglutide 14 mg

Arm Description

The semaglutide 7 mg tablet taken orally with upto120 ml of water.

The placebo tablet taken orally with 120 ml of water.

The semaglutide 14 mg tablet taken with upto 120 ml of water.

Outcomes

Primary Outcome Measures

Growth hormone peak
Maximum concentration measured after study medication administration.

Secondary Outcome Measures

Cortisol peak
Maximum concentration measured after study medication administration.
Adrenocorticotropin (ACTH) peak
Maximum concentration measured after study medication administration.
Aldosterone peak
Maximum concentration measured after study medication administration.
Glucose nadir
Lowest glucose concentration measured after study medication administration
C-peptide peak
Maximum concentration measured after study medication administration.
Copeptin peak
Maximum concentration measured after study medication administration

Full Information

First Posted
April 28, 2021
Last Updated
February 19, 2023
Sponsor
University of Tartu
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1. Study Identification

Unique Protocol Identification Number
NCT04865744
Brief Title
The Effect of Semaglutide on Pituitary Function
Official Title
The Effect of Semaglutide on Pituitary Function
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tartu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Blinded Randomised Single-group Crossover
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral semaglutide 7 mg
Arm Type
Active Comparator
Arm Description
The semaglutide 7 mg tablet taken orally with upto120 ml of water.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo tablet taken orally with 120 ml of water.
Arm Title
Oral semaglutide 14 mg
Arm Type
Active Comparator
Arm Description
The semaglutide 14 mg tablet taken with upto 120 ml of water.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 7 MG Oral Tablet
Other Intervention Name(s)
Rybelsus 7 mg
Intervention Description
Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet is taken after an overnight fast with up to120 ml of water.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 14 MG Oral Tablet
Other Intervention Name(s)
Rybelsus 14 mg
Intervention Description
Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.
Primary Outcome Measure Information:
Title
Growth hormone peak
Description
Maximum concentration measured after study medication administration.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary Outcome Measure Information:
Title
Cortisol peak
Description
Maximum concentration measured after study medication administration.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Adrenocorticotropin (ACTH) peak
Description
Maximum concentration measured after study medication administration.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Aldosterone peak
Description
Maximum concentration measured after study medication administration.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Glucose nadir
Description
Lowest glucose concentration measured after study medication administration
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
C-peptide peak
Description
Maximum concentration measured after study medication administration.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Copeptin peak
Description
Maximum concentration measured after study medication administration
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Other Pre-specified Outcome Measures:
Title
Nausea
Description
The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Heart rate
Description
The change in heart rate compared to baseline
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration
Title
Blood pressure
Description
The change in blood pressure compared to baseline
Time Frame
60, 90, 120, 150, 180 and 240 minutes after study medication administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-50 years The body weight >65 kg Exclusion Criteria: presence of chronic illness the daily use of medications pregnancy lactation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vallo Volke, MD, PhD
Organizational Affiliation
University of Tartu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51004
Country
Estonia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Semaglutide on Pituitary Function

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