How fasting time and briefly stopping GLP-1 medicines change how much food stays in the stomach for people on liraglutide or semaglutide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Altasciences Clinical LA, Inc.
  Cypress, California, United States Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.