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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-11-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Semaglutide

Group Type EXPERIMENTAL

Semaglutide D Dose 1

Intervention Type DRUG

Tablet given orally

Semaglutide D Dose 2

Intervention Type DRUG

Tablet given orally

Semaglutide D Dose 3

Intervention Type DRUG

Tablet given orally

Semaglutide C Dose 4

Intervention Type DRUG

Tablet given orally

Semaglutide C Dose 5 (50 mg)

Intervention Type DRUG

Tablet given orally

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (Semaglutide C)

Intervention Type DRUG

Tablet given orally

Placebo ( Semaglutide D)

Intervention Type DRUG

Tablet given orally

Interventions

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Semaglutide D Dose 1

Tablet given orally

Intervention Type DRUG

Semaglutide D Dose 2

Tablet given orally

Intervention Type DRUG

Semaglutide D Dose 3

Tablet given orally

Intervention Type DRUG

Semaglutide C Dose 4

Tablet given orally

Intervention Type DRUG

Semaglutide C Dose 5 (50 mg)

Tablet given orally

Intervention Type DRUG

Placebo (Semaglutide C)

Tablet given orally

Intervention Type DRUG

Placebo ( Semaglutide D)

Tablet given orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes