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

Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Drug: Semaglutide; Drug: Placebo

• Registration Number: NCT03842202
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study Start: 2019-02-15
• Study First Posted: 2019-02-15
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state	0 to 5 hours after standardised meal (day 142)	Measured in h\*micrograms/mL

Secondary Outcome Measures

Name	Time	Method
AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state	0 to 1 hour after standardised meal (day 142)	Measured in h\*micrograms/mL
Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours	0 to 5 hours after standardised meal (day 142)	Measured in micrograms/mL
Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours	0 to 5 hours after standardised meal (day 142)	Measured in hours
Energy intake during ad libitum lunch	Day 142	Measured in kilojoules
Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal	Day 142	Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal	Day 142	Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal	Day 142	Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal	Day 142	Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal	Day 142	Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany