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Recruiting NCT07225816

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)

Phase I Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liraglutide, Oral Semaglutide, Semaglutide.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Liraglutide
    Participants will receive liraglutide subcutaneously.
  • Drug Oral Semaglutide
    Participants will receive semaglutide orally.
  • Drug Semaglutide
    Participants will receive semaglutide subcutaneously.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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 7, Day 40]
  • 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 11, Day 161]
  • 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 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) [Time frame: 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) [Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161]
  • 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 7, Day 141]
  • Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid 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 7, Day 44]
  • Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid 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 165]
  • Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid 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 8, Day 148]
  • Gastric volume after fasting following liquid 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 7, Day 44]
  • Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily [Time frame: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165]
  • Gastric volume after fasting following a liquid 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 8, Day 148]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Altasciences Clinical LA, Inc. — Cypress

Identifiers

NCT: NCT07225816 · NN9536-8438 · U1111-1323-7355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗