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

Sponsor
Novo Nordisk A/S
Study ID
NCT05236517
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 8, 2022
Status verified
Sep 2024
Primary completion
Sep 29, 2022
Completion
Nov 7, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Relative change in energy intake during ad libitum lunch [ Time Frame: Baseline to Day 140 ]

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