Obesity
Conditions
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.
Interventions
DRUGLiraglutide
Participants will receive liraglutide subcutaneously.
DRUGOral Semaglutide
Participants will receive semaglutide orally.
DRUGSemaglutide
Participants will receive semaglutide subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) | 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) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141 | Measured as count of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44 | Measured as mL/kg |
| Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165 | Measured as mL/kg |
| Gastric volume after fasting following a liquid meal after dosing of s.c. semaglutide once weekly | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148 | Measured as mL/kg |
| 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) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44 | Measured as count of participants |
| Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165 | Measured as count of participants |
| 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) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148 | 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 7, Day 48 | 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 once daily (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171 | 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 oral semaglutide once daily (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178 | 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 9, Day 153 | 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 10, Day 160 | Measured as count of participants. |
| 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 7, Day 48 | 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 12, Day 171 | Measured as mL/kg |
| 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 13, Day 178 | 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 9, Day 153 | 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 10, Day 160 | Measured as mL/kg |
| 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 7, Day 48 | 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 12, Day 171 | 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 oral semaglutide once daily (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178 | 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 9, Day 153 | 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 2.4 mg once weekly (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160 | Measured as count of participants. |
| Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1 | Measured as count of participants. |
| Gastric volume after fasting following a solid, high-fat meal | 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 (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 liquid meal (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5 | Measured as count of participants. |
| Gastric volume after fasting following a liquid meal | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5 | Measured as mL/kg |
| Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal (Yes/No) | 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5 | Measured as count of participants. |
Countries
United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed