About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m²) (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator.
Disqualifiers
Known or suspected hypersensitivity to study intervention(s) (including paracetamol) or related products.
Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval) and occasional use of paracetamol/acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
Alanine Aminotransferase (ALT) greater than or equal to (>= ) 2.5 times the upper limit of normal (ULN)
Aspartate Aminotransferase (AST) >=2.5 times ULN
Trial design
Parallel
Treatments tested in this trial
Semaglutide
DrugSemaglutide will be administered in the thigh, abdomen, or upper arm of body part.
Placebo semaglutide
DrugPlacebo matched to semaglutide will be administered in the thigh, abdomen, or upper arm of body part.
Paracetamol
DrugParacetamol is administered orally as part of a standardised meal to assess gastric emptying through pharmacokinetic evaluation.
Treatment groups
Trial outcomes
Primary outcomes
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Measured in hour micrograms per millilitre (h\*µg/mL).
Secondary outcomes
AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal
Measured in h\*μg/mL.
Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal
Measured in microgram per millilitre (μg/mL).
tmax;para: Time to maximum observed paracetamol plasma concentration
Measured in hours.
Sponsors and contacts
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