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)
- Registration Number
- NCT07225816
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- On maintenance treatment with either liraglutide 3.0 milligram (mg) for at least 5 days, oral semaglutide 14 mg (R1 formulation) or 9 mg (R2 formulation) for at least 5 weeks or semaglutide 2.4 mg for at least 5 weeks prior to screening.
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Previous dosing in this study.
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Previous rescreening for this study.
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Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
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Current participation (i.e., signed informed consent) in any other interventional clinical study.
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Exposure to investigational medicinal products, except maintenance treatment with liraglutide 3.0 mg, oral semaglutide 9 or 14 mg, or semaglutide 2.4 mg as required by the inclusion criterion, within 30 days or 5 half-lives of the investigational medicinal product (if known), which-ever is longer, before screening (Visit 1).
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Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.
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Participant is the investigator or other site staff or relative thereof directly involved in the conduct of the study.
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Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the study as judged by the investigator.
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Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
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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 a*.
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Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 30 milliliter per min per 1.73 square meter (ml/min/1.73 m^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation according to Kidney Disease Improving Global Outcomes (KDIGO) 20246.
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Current treatment with insulin or secretagogues that might cause hypoglycaemia during periods of fasting.
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History of ketoacidosis.
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Diagnosed with or suspected to suffer from gastroparesis, hiatal hernia or severe gastroesophageal reflux diseases with daily symptoms and/or in supine position.
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Use of other medications known to affect the motility of the stomach.
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Inability to lie in the right lateral decubitus position for gastric ultrasonography.
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Unusual meal habits and special diet requirements or unwillingness to eat the meals provided in the study.
- As declared by the participant or reported in the medical records.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide Liraglutide Participants will receive liraglutide once daily subcutaneously. Oral semaglutide Semaglutide Participants will receive semaglutide once daily orally. Semaglutide Semaglutide Participants will receive semaglutide once weekly subcutaneously.
- Primary Outcome Measures
Name Time Method 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 2, Day 1 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 2, Day 1 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 2, Day 1 Measured as count of participants.
- Secondary Outcome Measures
Name Time Method Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 14 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal 2 days after dosing of s.c. semaglutide once weekly 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 Measured as milliliters per kilogram (mL/kg).
Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 Measured as mL/kg.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 14 Measured as count of participants.
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) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 Measured as count of participants.
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) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 Measured as count of participants.
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5 Measured as count of participants
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide 14 mg once daily (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7 Measured as count of participants.
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21 Measured as count of participants.
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 2 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9 Measured as count of participants.
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14 Measured as count of participants.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5 Measured as count of participants.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7 Measured as count of participants.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 2 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9 Measured as count of participants.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14 Measured as count of participants.
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly (Yes/No) 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21 Measured as count of participants.
Trial Locations
- Locations (1)
Altasciences Clinical LA, Inc.
🇺🇸Cypress, California, United States
Altasciences Clinical LA, Inc.🇺🇸Cypress, California, United States