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)
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- Recruiting
- Altasciences Clinical LA, Inc.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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]
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Liraglutide
Participants will receive liraglutide subcutaneously.
|
Participants will receive liraglutide subcutaneously.
|
|
Experimental: Oral semaglutide
Participants will receive semaglutide orally.
|
Participants will receive semaglutide orally.
|
|
Experimental: Semaglutide
Participants will receive semaglutide subcutaneously.
|
Participants will receive semaglutide subcutaneously.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as mL/kg.
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as mL/kg.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants.
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as mL/kg
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as mL/kg
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as mL/kg
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as mL/kg.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
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
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as mL/kg
|
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)
Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Gastrointestinal Hormones
- Glucagon-Like Peptides
- Proglucagon
- Glucagon-Like Peptide 1
- Liraglutide
- semaglutide
Other Study ID Numbers
Other Study ID Numbers
- NN9536-8438
- U1111-1323-7355 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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