Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

NCT03638778 · Completed

Last updated 2026-05-28

This study is testing how different tablets of the medicine semaglutide are absorbed in the body over 24 hours after 10 doses in healthy men.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 105 people

Who can join Ages 18–64 · male only Healthy volunteers accepted.

Timeline Started 2018-08 · est. completion 2018-12

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT03638778 ↗

Description as written by the study sponsor.

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Treatments tested

Semaglutide 3 mg Drug

Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.
Semaglutide 7 mg Drug

Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
Semaglutide B 3 mg Drug

Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.
Semaglutide B 7 mg Drug

Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
Semaglutide C 3 mg Drug

Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.
Semaglutide C 7 mg Drug

Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
Semaglutide D 3 mg Drug

Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.
Semaglutide D 7 mg Drug

Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Main thing measured	AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03638778 ↗