A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

NCT04152915 · Completed

Last updated 2026-05-28

This study compares how two different injection pens deliver the same dose of semaglutide in healthy volunteers and people with type 2 diabetes after a 6-week dose escalation period.

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 68 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2019-11 · est. completion 2020-05

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT04152915 ↗

Description as written by the study sponsor.

The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Treatments tested

Semaglutide Drug

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks

Main thing measured	AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Sponsor	Novo Nordisk A/S
Conditions studied	Healthy Volunteers, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04152915 ↗