A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03842202

2018-002497-42 (Registry Identifier)

U1111-1215-9915 (Other Identifier)

NN9536-4455

Details and patient eligibility

About

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 30.0 and 45.0 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 subject's 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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72 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.

Treatment:

Drug: Semaglutide

Placebo (Semaglutide)

Placebo Comparator group

Description:

Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks

Treatment:

Drug: Placebo