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

Obesity Clinical Trial

Official title:

Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842202
• Other study ID #: NN9536-4455
• Secondary ID: U1111-1215-99152
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: December 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.
• Placebo
Participants will receive once weekly injections of semaglutide matched placebo.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 subjects with obesity. Diabetes Obes Metab. 2020 Dec 2. doi: 10.1111/dom.14 — View Citation

Outcome

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