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: 71
• 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 7, Day 40

• 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 11, Day 161

• 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 7, Day 141

Secondary Outcomes (36)

• 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 7, Day 40

• 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 11, Day 161

• 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 7, Day 141

• 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 7, Day 40

• 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)

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

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:

• 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 \[stable dose is defined as the maximum daily tolerated dose for more than or equal to (≥) 90 days before screening\]

You may not qualify if:

• 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

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): December 13, 2026
• Study Completion (Estimated): January 6, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)