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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)

ConditionObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liraglutide

    Drug

    Participants will receive liraglutide subcutaneously.

  • Oral Semaglutide

    Drug

    Participants will receive semaglutide orally.

  • Semaglutide

    Drug

    Participants will receive semaglutide subcutaneously.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: LiraglutideExperimental treatment 1 intervention
Group B: Oral semaglutideExperimental treatment 1 intervention
Group C: SemaglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
3

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.

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

Secondary outcomes

1

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

Measured as milliliters per kilogram (mL/kg).

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

Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily

Measured as mL/kg.

Time frame
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
3

Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly

Measured as mL/kg.

Time frame
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
4

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)

Measured as count of participants.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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