NCT05236517

A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

The Effect of Oral Semaglutide 50 mg Once-daily on Energy Intake, Gastric Emptying, Appetite, Control of Eating and Pharmacokinetics in Participants With Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal. In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks. The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide D Dose 1	Tablet given orally
DRUG	Semaglutide D Dose 2	Tablet given orally
DRUG	Semaglutide D Dose 3	Tablet given orally
DRUG	Semaglutide C Dose 4	Tablet given orally
DRUG	Semaglutide C Dose 5 (50 mg)	Tablet given orally
DRUG	Placebo (Semaglutide C)	Tablet given orally
DRUG	Placebo ( Semaglutide D)	Tablet given orally

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-09-29
• Completion: 2022-11-07
• First posted: 2022-02-11
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany