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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)

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)

Recruiting
18 years and older
All
Phase 1

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Overview

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

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 (\<) 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 clinically significant 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.

Study details
    Obesity

NCT07225816

Novo Nordisk A/S

1 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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