A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

NCT04228354 · Completed

Last updated 2026-05-28

This study is testing whether two different versions of the drug semaglutide are absorbed similarly in the body in healthy people, those who are overweight, or those with obesity.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 28 people

Who can join Ages 18–55 · all sexes Healthy volunteers accepted.

Timeline Started 2020-01 · est. completion 2020-06

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT04228354 ↗

Description as written by the study sponsor.

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 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

Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks

Main thing measured	Area under the semaglutide plasma concentration curve from 0 to tz
Sponsor	Novo Nordisk A/S
Conditions studied	Healthy Volunteers, Overweight, Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04228354 ↗