Current partner codePEPTIDESDE
NCT07225816·Phase 1·INTERVENTIONAL

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)

Status

Recruiting

Phase

Phase 1

Enrollment

71

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Liraglutide

Participants will receive liraglutide subcutaneously.

DRUG

Oral Semaglutide

Participants will receive semaglutide orally.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

Timeline

From registration to results.

  1. First posted

    Nov 10, 2025

  2. Study start

    Nov 7, 2025

  3. Primary completion

    Dec 13, 2026

  4. Study completion

    Jan 6, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary outcomes

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

Measured as count of participants.

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

Measured as count of participants.

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

Measured as count of participants.

Secondary outcomes

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

Measured as milliliters per kilogram (mL/kg).

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

Measured as mL/kg.

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

Measured as mL/kg.

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

Measured as count of participants.

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

Measured as count of participants.

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

Measured as count of participants.

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

Measured as count of participants

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

Measured as count of participants.

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

Measured as count of participants.

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

Measured as mL/kg

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Altasciences Clinical LA, Inc.

Cypress, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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