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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Semaglutide D Dose 3; Drug: Semaglutide C Dose 4; Drug: Semaglutide D Dose 1; Drug: Placebo (Semaglutide C); Drug: Semaglutide C Dose 5 (50 mg); Drug: Semaglutide D Dose 2; Drug: Placebo ( Semaglutide D)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05236517

NN9932-4873

U1111-1266-4375 (Other Identifier)

2021-003341-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Treatment:

Drug: Semaglutide D Dose 2

Drug: Semaglutide C Dose 5 (50 mg)

Drug: Semaglutide D Dose 1

Drug: Semaglutide C Dose 4

Drug: Semaglutide D Dose 3

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo ( Semaglutide D)

Drug: Placebo (Semaglutide C)