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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Participants will receive liraglutide subcutaneously.
Participants will receive semaglutide orally.
Participants will receive semaglutide subcutaneously.
Altasciences Clinical LA, Inc.
Cypress, California, United States
RECRUITINGOccurrence 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily
Measured as milliliters per kilogram (mL/kg).
Time frame: 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
Measured as mL/kg.
Time frame: 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
Measured as mL/kg.
Time frame: 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants
Time frame: 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)
Measured as count of participants.
Time frame: 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)
Measured as count of participants.
Time frame: 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
Measured as mL/kg
Time frame: 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
Measured as mL/kg
Time frame: 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
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
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)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No)
Measured as count of participants
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
Gastric volume after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
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)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
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 2.4 mg once weekly (Yes/No)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal (Yes/No)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
Gastric volume after fasting following a solid, high-fat meal
Measured as mL/kg.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal (Yes/No)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal (Yes/No)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
Gastric volume after fasting following a liquid meal
Measured as mL/kg
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal (Yes/No)
Measured as count of participants.
Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
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