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AzTrials

ObesityPhase 1NCT07225816

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)

A Phase 1 study testing Liraglutide, Oral Semaglutide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Liraglutide, Oral Semaglutide and Semaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteUnited States
Study dates
7 Nov 2025to 6 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Altasciences Clinical LA, Inc.

    Cypress, California, 90630

    Recruiting

Other trials in United States

About this study

Official 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

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.

Conditions
Obesity
Being tested
Liraglutide, Oral Semaglutide, Semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Participants will receive liraglutide subcutaneously.

  • Oral SemaglutideDrug

    Participants will receive semaglutide orally.

  • SemaglutideDrug

    Participants will receive semaglutide subcutaneously.

Study groups in NCT07225816
Study groupRoleWhat they receive
LiraglutideExperimentalParticipants will receive liraglutide subcutaneously.
Receives: Drug: Liraglutide
Oral semaglutideExperimentalParticipants will receive semaglutide orally.
Receives: Drug: Oral Semaglutide
SemaglutideExperimentalParticipants will receive semaglutide subcutaneously.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141

Secondary outcomes (36)
  1. 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).

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40

  2. Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily

    Measured as mL/kg.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161

  3. Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly

    Measured as mL/kg.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148

  10. Gastric volume after fasting following liquid meal after dosing of s.c. liraglutide once daily

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44

  11. Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165

  12. Gastric volume after fasting following a liquid meal after dosing of s.c. semaglutide once weekly

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171

  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)

    Measured as count of participants

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160

  21. Gastric volume after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48

  22. Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171

  23. Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178

  24. Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153

  25. Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153

  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)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160

  31. Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal (Yes/No)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

  32. Gastric volume after fasting following a solid, high-fat meal

    Measured as mL/kg.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

  33. Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal (Yes/No)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

  34. Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal (Yes/No)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5

  35. Gastric volume after fasting following a liquid meal

    Measured as mL/kg

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5

  36. Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal (Yes/No)

    Measured as count of participants.

    Measured: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2025
  2. Study start7 Nov 2025
  3. Primary completion13 Dec 2026 (estimated)
  4. Study completion6 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07225816
Sponsor's protocol ID
NN9536-8438
Other IDs
U1111-1323-7355
Status last verified
Jul 2026
First submitted
5 Nov 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Liraglutide, Oral Semaglutide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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