NCT05232708

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

A Study to Demonstrate Bioequivalence Between Semaglutide Formulation for the DV3396 Pen-injector and the Formulation for the PDS290 Semaglutide Pen-injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers (Diabetes Mellitus, Type 2)

Interventions

Type	Name	Description
DRUG	Semaglutide B, 1.34 mg/mL	Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
DRUG	Semaglutide D, 1.0 mg/mL	Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
DRUG	Semaglutide D, 1.0 mg/mL	Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
DRUG	Semaglutide B, 1.34 mg/mL	Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2022-02-10
• Last updated: 2024-01-26

Locations

1 site across 1 country: United Kingdom