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)
NCT ID: NCT07225816
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
75 participants
INTERVENTIONAL
2025-11-07
2026-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liraglutide
Participants will receive liraglutide once daily subcutaneously.
Liraglutide
Participants will receive liraglutide subcutaneously.
Oral semaglutide
Participants will receive semaglutide once daily orally.
Semaglutide
Participants will receive semaglutide either orally or subcutaneously.
Semaglutide
Participants will receive semaglutide once weekly subcutaneously.
Semaglutide
Participants will receive semaglutide either orally or subcutaneously.
Interventions
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Liraglutide
Participants will receive liraglutide subcutaneously.
Semaglutide
Participants will receive semaglutide either orally or subcutaneously.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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 9 or 14 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 (\<) 30 milliliter per min per 1.73 square meter (ml/min/1.73 m\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation according to Kidney Disease Improving Global Outcomes (KDIGO) 20246.
* Current treatment with insulin or secretagogues that might cause hypoglycaemia during periods of fasting.
* History of ketoacidosis.
* Diagnosed with or suspected to suffer from gastroparesis, hiatal hernia or severe gastroesophageal reflux diseases with daily symptoms and/or in supine position.
* Use of other medications known to affect the motility of the stomach.
* Inability to lie in the right lateral decubitus position for gastric ultrasonography.
* Unusual meal habits and special diet requirements or unwillingness to eat the meals provided in the study.
1. As declared by the participant or reported in the medical records.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Altasciences Clinical LA, Inc.
Cypress, California, United States
Countries
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Central Contacts
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Other Identifiers
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U1111-1323-7355
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-8438
Identifier Type: -
Identifier Source: org_study_id