How fasting time and briefly stopping GLP-1 medicines change how much food stays in the stomach for people on liraglutide or semaglutide
Investigation of the Effect of Fasting Duration and Temporary Withholding of GLP-1 RAs on Retained Gastric Contents in Participants Treated With s.c. Liraglutide, Oral Semaglutide or s.c. Semaglutide
This trial will test whether different fasting durations and a short pause in GLP-1 medications change how much food remains in the stomach for adults taking liraglutide or semaglutide.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT07225816 on ClinicalTrials.gov |
What this trial studies
Adults with obesity who are already on maintenance liraglutide or semaglutide will follow different fasting schedules and, in some visits, temporarily stop their GLP-1 medication. The amount of food left in the stomach after a test meal will be measured under these different conditions. Participants remain in the study for a period that depends on which GLP-1 formulation and dose they are using at baseline. The goal is to compare gastric retention across fasting lengths and temporary medication pauses to inform practical guidance for people using these drugs.
Who should consider this trial
Good fit: Adults with obesity who are on maintenance treatment with liraglutide 3.0 mg (≥5 days) or oral semaglutide 25 mg or injectable semaglutide 2.4 mg (both ≥5 weeks) are the intended participants.
Not a fit: People not taking these specific GLP-1 medications, those who are pregnant or breastfeeding, or those with medical conditions that make participation unsafe are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, results could help clinicians give clearer advice about fasting and temporarily pausing GLP-1 drugs for procedures or symptom management.
How similar studies have performed: Prior research has shown GLP-1 medications can slow gastric emptying, but effects vary by drug and duration of use, so this targeted comparison adds relatively novel, practical detail.
Eligibility criteria
Show full inclusion / exclusion 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 (\<) 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.
Where this trial is running
Cypress, California
- Altasciences Clinical LA, Inc. — Cypress, California, United States (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.