The Effect of Semaglutide on Pituitary Function

NCT ID: NCT04865744

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinded Randomised Single-group Crossover
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Oral semaglutide 7 mg

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

Group Type ACTIVE_COMPARATOR

Semaglutide 7 MG Oral Tablet

Intervention Type DRUG

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

Placebo

The placebo tablet taken orally with 120 ml of water.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Oral semaglutide 14 mg

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

Group Type ACTIVE_COMPARATOR

Semaglutide 14 MG Oral Tablet

Intervention Type DRUG

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

Interventions

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Semaglutide 7 MG Oral Tablet

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Semaglutide 14 MG Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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Rybelsus 7 mg Rybelsus 14 mg

Eligibility Criteria

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Inclusion Criteria

* Age 18-50 years
* The body weight \>65 kg

Exclusion Criteria

* presence of chronic illness
* the daily use of medications
* pregnancy
* lactation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Vallo Volke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vallo Volke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

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Tartu University Hospital

Tartu, , Estonia

Site Status

Countries

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Estonia

Other Identifiers

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Sema21

Identifier Type: -

Identifier Source: org_study_id

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