The Effect of Semaglutide on Pituitary Function

NCT04865744 | Completed Phase 4

• 1 other identifier: Sema21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Growth hormone peak

  Maximum concentration measured after study medication administration.

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

Secondary Outcomes (6)

• Cortisol peak

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

• Adrenocorticotropin (ACTH) peak

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

• Aldosterone peak

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

• Glucose nadir

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

• C-peptide peak

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

Other Outcomes (3)

• Nausea

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

• Heart rate

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

• Blood pressure

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

Study Arms (3)

Oral semaglutide 7 mg

ACTIVE COMPARATOR

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

Drug: Semaglutide 7 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

The placebo tablet taken orally with 120 ml of water.

Drug: Placebo

Oral semaglutide 14 mg

ACTIVE COMPARATOR

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

Drug: Semaglutide 14 MG Oral Tablet

Interventions

Semaglutide 7 MG Oral Tablet DRUG

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

Also known as: Rybelsus 7 mg

Oral semaglutide 7 mg

Placebo DRUG

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

Placebo

Semaglutide 14 MG Oral Tablet DRUG

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

Also known as: Rybelsus 14 mg

Oral semaglutide 14 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Tartu University Hospital

Tartu, 51004, Estonia

Location

MeSH Terms

Interventions

semaglutide; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Vallo Volke, MD, PhD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Blinded Randomised Single-group Crossover

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: May 19, 2021
• Primary Completion: September 23, 2021
• Study Completion: September 30, 2021
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)