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)

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Liraglutide
  Participants will receive liraglutide subcutaneously.
• Препарат Oral Semaglutide
  Participants will receive semaglutide orally.
• Препарат Semaglutide
  Participants will receive semaglutide subcutaneously.

Первичные конечные точки

• 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) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40]
• 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) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161]
• 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) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141]

Вторичные конечные точки (12)

• Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40]
• Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161]
• Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141]
• Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40]
• Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161]
• Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141]
• Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44]
• Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165]
• Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No) [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148]
• Gastric volume after fasting following liquid meal after dosing of s.c. liraglutide once daily [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44]
• Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165]
• Gastric volume after fasting following a liquid meal after dosing of s.c. semaglutide once weekly [Срок оценки: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148]

Критерии участия

Критерии включения

• 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 \[stable dose is defined as the maximum daily tolerated dose for more than or equal to (≥) 90 days before screening\]

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Altasciences Clinical LA, Inc. — Cypress

Идентификаторы

NCT: NCT07225816 · NN9536-8438 · U1111-1323-7355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗