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)
| NCT ID | NCT07225816 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2026-12-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 71 participants in total. It began in 2025-11-07 with a primary completion date of 2026-12-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: * Male or female. * Age 18 years or above at the time of signing the informed consent. * BMI between 25.0 and 45 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. For participants with T2D: * Diagnosed with type 2 diabetes (T2D) more than (\>) 180 days before screening. * Treatment with: 1. no antidiabetic drugs or 2. stable metformin dose or both \[stable dose is defined as the maximum daily tolerated dose for more than or equal to (≥) 90 days before screening\] Exclusion Criteria: * 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. * Diagnosed with or suspected to suffer from clinically significant gastroparesis, hiatal hernia or severe gastro-oesophageal 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. For participants without T2D: \- Glycosylated hemoglobin (HbA1c) \> 6.5 percent (%) 48 millimole per mole (mmol/mol) at screening. For participants with T2D: * HbA1c ≥ 10.5 % (91 mmol/mol) at screening. * Current treatment with insulin or insulin secretagogues that might increase risk of hypoglycaemia during periods of fasting. * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days before screening
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07225816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225816 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07225816 currently recruiting?
Yes, NCT07225816 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07225816 trial being conducted?
This trial is being conducted at Cypress, United States.
Who is sponsoring the NCT07225816 clinical trial?
NCT07225816 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 71 participants.
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