Clinical trial NCT03842202: A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
Official title: Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state
timeFrame: 0 to 5 hours after standardised meal (day 142)
Secondary outcomes:
measure: AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state
timeFrame: 0 to 1 hour after standardised meal (day 142)
measure: Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours
timeFrame: 0 to 5 hours after standardised meal (day 142)
measure: Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours
timeFrame: 0 to 5 hours after standardised meal (day 142)
measure: Energy intake during ad libitum lunch
timeFrame: Day 142
measure: Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal
timeFrame: Day 142
measure: Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
timeFrame: Day 142
measure: Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
timeFrame: Day 142
measure: Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
timeFrame: Day 142
measure: Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
timeFrame: Day 142
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.