Obesity Clinical Trial
Official title:
Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity
Verified date | December 2020 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Novo Nordisk Investigational Site | Berlin |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Germany,
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
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 |
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