Clinical trial

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 now · Phase 1 · 1 countries · Registry ID NCT07225816

Recruiting nowPhase 1Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Liraglutide

Drug

Participants will receive liraglutide subcutaneously.

Oral Semaglutide

Drug

Participants will receive semaglutide orally.

Semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Primary outcomes

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of subcutaneous (s.c.) liraglutide once daily (Yes/No)6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40

Measured as count of participants.

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161

Measured as count of participants.

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141

Measured as count of participants.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Altasciences Clinical LA, Inc.🇺🇸 Cypress, California, United States