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HomeTrials › NCT07225816

Obesity & weight · Phase 1 · Recruiting now

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)

NCT07225816 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is recruiting now at 1 US site. It's studying Liraglutide, Oral Semaglutide, Semaglutide for obesity.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeLiraglutide, Oral Semaglutide, Semaglutide
Study length~7 months overall
Planned participants75
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

California

  • Altasciences Clinical LA, Inc. — Cypress · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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