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A Research Study Looking Into How a High Dose of s.c. Semaglutide Works With Emptying of the Stomach in People With Excess Body Weight
Plain-language guide to NCT07845578: phase 1 randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07845578
- Phase
- phase 1
- Status
- not yet recruiting
- Start
- 2026-09-25
- Completion (planned or actual)
- 2027-09-11
- Participants
- 60 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Semaglutide.
The purpose of the study is to determine the effect of semaglutide on gastric emptying in people with obesity.
Participants will receive either semaglutide or placebo, and the treatment assigned will be decided by chance.
Semaglutide is a medicine that doctors can already prescribe, while placebo contains no active medicine.
It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 60 planned participants were the target.
It was open to people of any sex aged from 18 years up to 64 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18-64 years (both inclusive) at the time of signing the informed consent. Male or female (sex assigned at birth, inclusive of all gender identities). Body mass index (BMI) between 30.0 - 44.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) (including paracetamol) or related products; impaired liver function defined as any of the below:; alanine aminotransferase (alt) greater than or equal to (\>= ) 2.5 times the upper limit of normal (uln).
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2026-09-25 with completion listed for 2027-09-11.
It ran at 1 site in Austria.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal (time frame: Day 177).
It also tracked 3 secondary outcomes, for example AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal, Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal and tmax;para: Time to maximum observed paracetamol plasma concentration.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 60 people.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.