Back to resultsA Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Semaglutide
Placebo (Semaglutide)
Arm 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.
Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks
Outcomes
Primary Outcome Measures
AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state
Measured in h*micrograms/mL
Secondary Outcome Measures
AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state
Measured in h*micrograms/mL
Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours
Measured in micrograms/mL
Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours
Measured in hours
Energy intake during ad libitum lunch
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
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
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
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
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
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03842202
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide
Arm Type
Experimental
Arm 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.
Arm Title
Placebo (Semaglutide)
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive once weekly injections of semaglutide matched placebo.
Primary Outcome Measure Information:
Title
AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state
Description
Measured in h*micrograms/mL
Time Frame
0 to 5 hours after standardised meal (day 142)
Secondary Outcome Measure Information:
Title
AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state
Description
Measured in h*micrograms/mL
Time Frame
0 to 1 hour after standardised meal (day 142)
Title
Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours
Description
Measured in micrograms/mL
Time Frame
0 to 5 hours after standardised meal (day 142)
Title
Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours
Description
Measured in hours
Time Frame
0 to 5 hours after standardised meal (day 142)
Title
Energy intake during ad libitum lunch
Description
Measured in kilojoules
Time Frame
Day 142
Title
Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal
Description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Time Frame
Day 142
Title
Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
Description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Time Frame
Day 142
Title
Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
Description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Time Frame
Day 142
Title
Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
Description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Time Frame
Day 142
Title
Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal
Description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.
Time Frame
Day 142
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Citations:
PubMed Identifier
33269530
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.
Results Reference
result
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A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
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