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)

NCT07225816 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9536-8438U1111-1323-7355
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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). The length of participants participation in the study will depend on the type of GLP-1 RA treatment participants are already using.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  Measured as count of participants.

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

Secondary Outcomes (24)

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

  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

  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

  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)

  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)

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

Study Arms (3)

Liraglutide

EXPERIMENTAL

Participants will receive liraglutide subcutaneously.

Drug: Liraglutide

Oral semaglutide

EXPERIMENTAL

Participants will receive semaglutide orally.

Drug: Oral Semaglutide

Semaglutide

EXPERIMENTAL

Participants will receive semaglutide subcutaneously.

Drug: Semaglutide

Interventions

Liraglutide DRUG

Participants will receive liraglutide subcutaneously.

Liraglutide

Oral Semaglutide DRUG

Participants will receive semaglutide orally.

Oral semaglutide

Semaglutide DRUG

Participants will receive semaglutide subcutaneously.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide; semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)