NCT04513704

A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times

Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The goal of this trial is to find out whether taking semaglutide tablets at different times before and after eating has a similar effect compared to the recommended dosing time. Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral medicine for at least 30 minutes after that. The trial will look at how different dosing times of semaglutide before and after eating a meal changes how much semaglutide participants get into their blood. Participants will get one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine (3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance under which dosing condition participants will receive the trial medicine: A 2 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial medicine, participants will fast for 4 hours and then receive a standardised meal. The meal should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with the study doctor. At one of the visits, participants will be admitted to the trial unit and have to stay for 12 consecutive days. At all visits participants will meet with trial staff and will have blood tests along with other clinical checks and tests. Participants will be asked about their health, medical history, and habits. Women only: Women cannot take part if pregnant, breast-feeding, or planning to become pregnant during the trial period.

Conditions

• Healthy Volunteers Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Oral Semaglutide	Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).

Timeline

• Start date: 2020-08-28
• Primary completion: 2021-04-20
• Completion: 2021-05-26
• First posted: 2020-08-14
• Last updated: 2023-05-12

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study