DRUG
Liraglutide
Participants will receive liraglutide subcutaneously.
Status
Recruiting
Phase
Phase 1
Enrollment
71
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Participants will receive liraglutide subcutaneously.
DRUG
Participants will receive semaglutide orally.
DRUG
Participants will receive semaglutide subcutaneously.
Timeline
First posted
Nov 10, 2025
Study start
Nov 7, 2025
Primary completion
Dec 13, 2026
Study completion
Jan 6, 2027
Results posted
Not reported
Registry updated
Jul 21, 2026
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)
Time frame · 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)
Time frame · 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)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
Measured as count of participants.
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
Measured as milliliters per kilogram (mL/kg).
Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
Measured as mL/kg.
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
Measured as mL/kg.
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)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
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 oral semaglutide once daily (Yes/No)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
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)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
Measured as count of participants.
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)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
Measured as count of participants
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
Measured as count of participants.
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)
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
Measured as count of participants.
Gastric volume after fasting following liquid meal after dosing of s.c. liraglutide once daily
Time frame · 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
Measured as mL/kg
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Altasciences Clinical LA, Inc.
Cypress, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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