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

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 71 人开始时间: 2025年11月7日最近更新: 2026年7月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Novo Nordisk A/S
入组人数: 71
试验地点: 1
主要终点: 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)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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]

排除标准

•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

研究组 & 干预措施

Semaglutide

Experimental

Participants will receive semaglutide subcutaneously.

干预措施: Semaglutide (Drug)

Liraglutide

Experimental

Participants will receive liraglutide subcutaneously.

干预措施: Liraglutide (Drug)

Oral semaglutide

Experimental

Participants will receive semaglutide orally.

干预措施: Oral Semaglutide (Drug)

结局指标

主要结局

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)

时间窗: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40