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Recruiting NCT07225816

Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected)

Conditions: Obesity

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 75
Sponsor: Novo Nordisk A/S

Location: Altasciences Clinical LA, Inc. Cypress California

Summary

The purpose of this study is to investigate how the duration of fasting and temporary stopping of Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach in people using liraglutide (injected), semaglutide (taken by mouth) or semaglutide (injected). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are already using.

Eligibility Criteria

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 Criteria: * Previous dosing in this study. * Previous rescreening for this study. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method * Current participation (i.e., signed informed consent) in any other interventional clinical study. * Exposure to investigational medicinal products, except maintenance treatment with liraglutide 3.0 mg, oral semaglutide 25 mg, or semaglutide 2.4 mg as required by the inclusion criterion, within 30 days or 5 half-lives of the investigational medicinal product (if known), which-ever is longer, before screening (Visit 1). * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study. * Participant is the investigator or other site staff or relative thereof directly involved in the conduct of the study. * Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the study as judged by the investigator. * Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator. * History of major surgical procedures involving the oesophagus or stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant a\*. * Renal impairment with estimated glomerular filtration rate (eGFR) less than (\

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Source: ClinicalTrials.gov (NCT07225816). StuddyBuddy aggregates publicly available trial information.