GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1

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

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Perioperative / gastric aspiration risk

Key I/E criterion

—

Primary endpoint

•Occurrence of empty stomach (antrum grade 0 or 1) after fasting following

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07225816

Org study IDNN9536-8438

Secondary IDU1111-1323-7355World Health Organization (WHO)

Timeline

Milestones

Study start2025-11-07actual

Study first posted2025-11-10actual

Last update posted2026-01-23actual

Primary completion2026-06-19estimated

Study completion2026-07-17estimated

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPerioperative / gastric aspiration risk

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

- On maintenance treatment with either liraglutide 3.0 milligram (mg) for at least 5 days, oral semaglutide 25 mg for at least 5 weeks or semaglutide 2.4 mg for at least 5 weeks prior to screening.

Exclusion criteria

•Previous dosing in this study.

•Previous rescreening for this study.

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method

•Current participation (i.e., signed informed consent) in any other interventional clinical study.

•Exposure to investigational medicinal products, except maintenance treatment with liraglutide 3.0 mg, oral semaglutide 25 mg, or semaglutide 2.4 mg as required by the inclusion criterion, within 30 days or 5 half-lives of the investigational medicinal product (if known), which-ever is longer, before screening (Visit 1).

•Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

•Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study.

•Participant is the investigator or other site staff or relative thereof directly involved in the conduct of the study.

•Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or co-operation during the study as judged by the investigator.

•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 a*.

•Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 30 milliliter per min per 1.73 square meter (ml/min/1.73 m^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation according to Kidney Disease Improving Global Outcomes (KDIGO) 20246.

•Current treatment with insulin or secretagogues that might cause hypoglycaemia during periods of fasting.

•History of ketoacidosis.

•Diagnosed with or suspected to suffer from clinically significant gastroparesis, hiatal hernia or severe gastroesophageal 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.

1. As declared by the participant or reported in the medical records.

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Other (unclassified)

Other clinical outcomes

21 endpoints

Primary/protocol endpoint

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 2, Day 1

categorical status, descriptive

Primary/protocol endpoint

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 2, Day 1

categorical status, improvement

Primary/protocol endpoint

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 2, Day 1

categorical status, descriptive

Secondary/protocol endpoint

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 2, Day 1

descriptive

Secondary/protocol endpoint

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 2, Day 1

categorical status, descriptive

Secondary/protocol endpoint

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 2, Day 1

categorical status, descriptive

Secondary/protocol endpoint

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 2, Day 1

categorical status, descriptive

Secondary/protocol endpoint

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 4, Day 5

threshold achievement, improvement

Secondary/protocol endpoint

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide 14 mg once daily (Yes/No)

Time frame:6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7

categorical status, descriptive

Secondary/protocol endpoint/low confidence

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 4, Day 14

categorical status, improvement

Secondary/protocol endpoint

Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 2 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 4, Day 9

categorical status, improvement

Secondary/protocol endpoint

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 5, Day 14

categorical status, improvement

Secondary/protocol endpoint/low confidence

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 6, Day 21

categorical status, improvement

Secondary/protocol endpoint

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 4, Day 14

descriptive

Secondary/protocol endpoint

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 5, Day 14

descriptive

Secondary/protocol endpoint

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 4, Day 5

categorical status, descriptive

Secondary/protocol endpoint

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 3, Day 7

categorical status, descriptive

Secondary/protocol endpoint

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 4, Day 14

categorical status, descriptive

Secondary/protocol endpoint

Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 2 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 4, Day 9

categorical status, descriptive

Secondary/protocol endpoint

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 5, Day 14

categorical status, improvement

Secondary/protocol endpoint

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 once weekly (Yes/No)

Time frame:6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21

categorical status, descriptive

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

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 2, Day 1

descriptive

Secondary/protocol endpoint/low confidence

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 2, Day 1

descriptive

Secondary/protocol endpoint/low confidence

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 4, Day 5

descriptive

Secondary/protocol endpoint/low confidence

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 3, Day 7

descriptive

Secondary/protocol endpoint/low confidence

Gastric volume after fasting following a solid, high-fat meal 2 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 4, Day 9

descriptive

Secondary/protocol endpoint/low confidence

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 6, Day 21

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.