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 · NCT07225816 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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:
- no antidiabetic drugs or
- 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 is running
1 location listed across 1 US state.
- Altasciences Clinical LA, Inc. - Cypress, California, United States