Recruiting
Phase 1

GLP-1

Sponsor:

Novo Nordisk A/S

Code:

NCT07225816

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Liraglutide

Oral Semaglutide

Semaglutide

Study Details

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

Study ID

NCT07225816

Start date

Nov 7, 2025

Status verified date

Jul, 2026

Completion date

Jan 6, 2027

Anticipated

Primary completion date

Dec 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. no antidiabetic drugs or
2. stable metformin dose or both \[stable dose is defined as the maximum daily tolerated dose for more than or equal to (≥) 90 days before screening\]

Exclusion Criteria:

  • 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

Study Design

Enrollment

71 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liraglutide

Participants will receive liraglutide subcutaneously.

experimental: Oral semaglutide

Participants will receive semaglutide orally.

experimental: Semaglutide

Participants will receive semaglutide subcutaneously.

Interventions

Liraglutide

Participants will receive liraglutide subcutaneously.

Oral Semaglutide

Participants will receive semaglutide orally.

Semaglutide

Participants will receive semaglutide subcutaneously.

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 ]
  • 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 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) [ Time Frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Altasciences Clinical LA, Inc.

Recruiting

Cypress, California, United States, 90630

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-07-21.