GLPwatch

A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

NCT04187300 · Completed

Last updated 2026-05-28

This study is testing whether two different pen-injectors deliver the same amount of semaglutide in people who are overweight or have obesity.

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
Timeline Started 2019-12 · est. completion 2020-09
Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT04187300 ↗

Description as written by the study sponsor.

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.

Treatments tested

Main thing measuredAUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
SponsorNovo Nordisk A/S
Conditions studiedOverweight, Obesity
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04187300 ↗