Obesity, Overweight
Conditions
Brief summary
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.
Interventions
DRUGSemaglutide
Semaglutide will be administered in the thigh, abdomen, or upper arm of body part.
Placebo matched to semaglutide will be administered in the thigh, abdomen, or upper arm of body part.
DRUGParacetamol
Paracetamol is administered orally as part of a standardised meal to assess gastric emptying through pharmacokinetic evaluation.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Impaired liver function defined as any of the below: 1. Alanine Aminotransferase (ALT) greater than or equal to (\>= ) 2.5 times the upper limit of normal (ULN) 2. Aspartate Aminotransferase (AST) \>=2.5 times ULN 3. Total bilirubin greater than (\>) 1.5 times ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal | Day 177 | Measured in hour micrograms per millilitre (h\*µg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC,para: The area under the paracetamol plasma concentration-time curve following a standardised meal | Day 177 | Measured in h\*μg/mL. |
| Cmax,para; Maximum observed paracetamol plasma concentration following a standardised meal | Day 177 | Measured in microgram per millilitre (μg/mL). |
| tmax;para: Time to maximum observed paracetamol plasma concentration | Day 177 | Measured in hours. |
Countries
Austria
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed