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NCT Number: NCT07225816

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)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Participants will receive liraglutide subcutaneously.

Oral semaglutide

Drug

Participants will receive semaglutide orally.

semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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.

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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

  36. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 10, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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