Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

NCT01572753 · Completed

Last updated 2026-05-28

This clinical trial tests different dosing conditions of a long-acting GLP-1 medication in healthy adult men to determine the best way to deliver the drug.

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 161 people

Who can join Ages 18–55 · male only Healthy volunteers accepted.

Timeline Started 2012-04 · est. completion 2012-09

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT01572753 ↗

Description as written by the study sponsor.

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.

Treatments tested

semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
semaglutide Drug

Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.

Main thing measured	AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01572753 ↗