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Completed

NCT Number: NCT04865744

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tartu University Hospital

Tartu, 51004, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Semaglutide 7 MG Oral Tablet

Drug

Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.

Other names: Rybelsus 7 mg

Placebo

Drug

Placebo tablet is taken after an overnight fast with up to120 ml of water.

Semaglutide 14 MG Oral Tablet

Drug

Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.

Other names: Rybelsus 14 mg

Primary outcomes

  1. Growth hormone peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration.

Secondary outcomes

  1. Cortisol peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration.

  2. Adrenocorticotropin (ACTH) peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration.

  3. Aldosterone peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration.

  4. Glucose nadir

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Lowest glucose concentration measured after study medication administration

  5. C-peptide peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration.

  6. Copeptin peak

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    Maximum concentration measured after study medication administration

Other outcomes

  1. Nausea

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea.

  2. Heart rate

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    The change in heart rate compared to baseline

  3. Blood pressure

    Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration

    The change in blood pressure compared to baseline

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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