Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT03842202Other idNN9536-4455Other idU1111-1215-9915Other id2018-002497-42Other id2018

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 72 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Germany
Start: 15 Feb 2019
Primary completion: 4 Nov 2019
Completion: 4 Nov 2019
First posted: 15 Feb 2019
Last update posted: 24 Dec 2020
Conditions: Overweight · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020

Ph 1
A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
NCT03842202
15 Feb 2019 to 4 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SemaglutideDrug
PlaceboDrug

Arms2

Experimental
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 comparator
Placebo (Semaglutide)
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 outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(9)

AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state
Time frame · 0 to 1 hour after standardised meal (day 142)
Registry description
Measured in h\*micrograms/mL
Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours
Time frame · 0 to 5 hours after standardised meal (day 142)
Registry description
Measured in micrograms/mL
Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours
Time frame · 0 to 5 hours after standardised meal (day 142)
Registry description
Measured in hours
Energy intake during ad libitum lunch
Time frame · Day 142
Registry description
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
Time frame · Day 142
Registry description
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
Time frame · Day 142
Registry description
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
Time frame · Day 142
Registry description
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
Time frame · Day 142
Registry description
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
Time frame · Day 142
Registry description
Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

12 results

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity.

Friedrichsen et al. 2021Diabetes, obesity & metabolismcited by 319

PMID 33269530PMC7898914DOI 10.1111/dom.14280PUB-33269530

Free to read · publisher termsCC BY-NC12 results

Read at source See results (12)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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