Phase
Condition
Diabetes Prevention
Obesity
Treatment
Semaglutide
Liraglutide
Oral Semaglutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- On maintenance treatment with either liraglutide 3.0 milligram (mg) for at least 5 days, oral semaglutide 25 mg for at least 5 weeks or semaglutide 2.4 mg for at least 5 weeks prior to screening.
Exclusion
Exclusion Criteria:
Previous dosing in this study.
Previous rescreening for this study.
Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using adequate contraceptive method
Current participation (i.e., signed informed consent) in any other interventionalclinical study.
Exposure to investigational medicinal products, except maintenance treatment withliraglutide 3.0 mg, oral semaglutide 25 mg, or semaglutide 2.4 mg as required by theinclusion criterion, within 30 days or 5 half-lives of the investigational medicinalproduct (if known), which-ever is longer, before screening (Visit 1).
Any condition which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol.
Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) duringthe study.
Participant is the investigator or other site staff or relative thereof directlyinvolved in the conduct of the study.
Mental incapacity, language barriers or unwillingness to comply with therequirements of the protocol, which may preclude adequate understanding orco-operation during the study as judged by the investigator.
Presence of clinically significant gastrointestinal disorders or symptoms ofgastrointestinal disorders potentially affecting absorption of drugs or nutrients,or as judged by the investigator.
History of major surgical procedures involving the oesophagus or stomach potentiallyaffecting absorption of trial products (e.g. subtotal and total gastrectomy, sleevegastrectomy, gastric bypass surgery) or current presence of gastrointestinal implanta*.
Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 30milliliter per min per 1.73 square meter (ml/min/1.73 m^2) at screening based on theChronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equationaccording to Kidney Disease Improving Global Outcomes (KDIGO) 20246.
Current treatment with insulin or secretagogues that might cause hypoglycaemiaduring periods of fasting.
History of ketoacidosis.
Diagnosed with or suspected to suffer from clinically significant gastroparesis,hiatal hernia or severe gastroesophageal reflux diseases with daily symptoms and/orin supine position.
Use of other medications known to affect the motility of the stomach.
Inability to lie in the right lateral decubitus position for gastricultrasonography.
Unusual meal habits and special diet requirements or unwillingness to eat the mealsprovided in the study.
- As declared by the participant or reported in the medical records.
Study Design
Connect with a study center
Altasciences Clinical LA, Inc.
Cypress 5341256, California 5332921 90630
United StatesActive - Recruiting

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