The Effect of Semaglutide on Pituitary Function

University of Tartu

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Semaglutide 7 MG Oral Tablet; Drug: Placebo; Drug: Semaglutide 14 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04865744

Sema21

Details and patient eligibility

About

The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups, including a placebo group

Oral semaglutide 7 mg

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide 7 MG Oral Tablet

Placebo

Placebo Comparator group

Description:

The placebo tablet taken orally with 120 ml of water.

Treatment:

Drug: Placebo

Oral semaglutide 14 mg

Active Comparator group

Description:

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

Treatment:

Drug: Semaglutide 14 MG Oral Tablet