drugset / Trial / NCT05232708

A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

NCT05232708

Phase 1 Completed 18 enrolled Novo Nordisk A/S
RandomizedCrossoverOpen-labelTreatment

Summary

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.

Timeline

Start
2022-01-19
Primary completion
2022-08-30
Completion
2022-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 0.5 mg Subcutaneous