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)

January 21, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Recruiting
        • Altasciences Clinical LA, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Participants will receive liraglutide subcutaneously.
Drug: Liraglutide
Participants will receive liraglutide subcutaneously.
Experimental: Oral semaglutide
Participants will receive semaglutide orally.
Drug: Oral Semaglutide
Participants will receive semaglutide orally.
Experimental: Semaglutide
Participants will receive semaglutide subcutaneously.
Drug: Semaglutide
Participants will receive semaglutide subcutaneously.

What is the study measuring?

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 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 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
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 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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1

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 2, Day 1
Measured as milliliters per kilogram (mL/kg).
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 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
Measured as mL/kg.
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 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
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 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
Measured as count of participants.
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 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
Measured as count of participants.
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 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
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 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
Measured as count of participants
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 14
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 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 4, Day 5
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5
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
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 14
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
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9
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
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14
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
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 5
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 14
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 4, Day 9
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 5, Day 14
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 6, Day 21
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
Measured as mL/kg.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7
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
Measured as count of participants.
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 3, Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

June 19, 2026

Study Completion (Estimated)

July 17, 2026

Study Registration Dates

First Submitted

November 5, 2025

First Submitted That Met QC Criteria

November 5, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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