Effects of Liraglutide on Body Surface Gastric Mapping

NCT06500130 | Completed

• 1 other identifier: 2024 FULL 19945
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: To investigate, in healthy participants, the effect of liraglutide injection on gastric electrophysiology (as measured by body surface gastric mapping using the Gastric Alimetry device) during an 13-dayramping dose of liraglutide and subsequent washout. Aim 2: Assessment of effect of liraglutide injection on gastrointestinal symptoms and gut-brain wellbeing (as measured by validated symptom App and Alimetry gut-brain wellness Scale, respectively) during an 13-day ramping dose of liraglutide and subsequent washout.

Conditions

Gastroparesis; Functional Dyspepsia; Chronic Nausea and Vomiting Syndrome; Healthy

Keywords

Liraglutide; GLP-1 Receptor Agonist; Gastric Motility; Body Surface Gastric Mapping; Gastric Emptying Breath Test

Outcome Measures

Primary Outcomes (1)

• Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.

  Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.

  2 weeks

Secondary Outcomes (9)

• Change in the following symptoms on treatment compared to baseline

  2 weeks

• Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline

  2 weeks

• Change in GA-RI on treatment to washout

  1 week

• Change in BMI-adjusted amplitude on treatment to washout

  1 week

• Correlation of total symptom burden with change in GA-RI

  4 weeks

Study Arms (1)

Liraglutide Group

EXPERIMENTAL

All study participants will be in this group and will have a total of three body surface gastric mapping tests conducted, pre, during and post liraglutide intervention.

Device: Body Surface Gastric Mapping

Interventions

Body Surface Gastric Mapping DEVICE

All study participants will be in this group and will have a total of three body surface gastric mapping tests conducted, pre, during and post liraglutide.

Liraglutide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form, AND
• Aged between 18 and 65 years old, AND
• Healthy volunteer with no previous history of gastrointestinal disorders/symptoms
• BMI 22-35

You may not qualify if:

• Confirmed diagnosis of a comorbidity known to affect gastric motility (i.e., Parkinson\'s Disease, Type 1 or 2 Diabetes).
• Medications in the last 3 months known to impact gastric motility.
• Any Gastric Surgery
• Pregnancy or lactation, determined by pregnancy test at timeof enrolment.
• Known allergy to adhesives and/or skin sensitivities, or any allergy to liraglutide or any components of the liraglutide/Saxenda formulation, or known hypersensitivity to Spirulina, egg, milk or wheat allergens
• Use of GLP-1 agonist and/or on regular insulin in the past 3months.
• History of gastroduodenal dysfunction and/or meets the ROME IV symptom criteria for a gastroduodenal disorder of gut-brain interaction (functional dyspepsia, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, rumination syndrome, cannabinoid hyperemesis syndrome, or a belching disorder).
• History of peptic ulcer, pancreatitis, cholelithiasis, choledocholithiasis, History of kidney or hepatic dysfunction
• History of psychiatric disturbance requiring medication in the year before enrolment, any history of suicide attempt or eating disorder
• History of Type II Diabetes or glucose intolerance (treated or untreated)
• History of cancer other than basal cell skin cancer, and patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
• History of angioedema or urticaria disorder
• History of cardiac disorder or arrhythmia
• Any tobacco, vaping or cannabinoid use in the 30 days prior to study

Sponsors & Collaborators

• Alimetry: lead

Study Sites (1)

Alimetry Clinic

Auckland, Auckland, 1010, New Zealand

Location

Related Links

• Gastric Alimetry® expands patient phenotyping in gastroduodenal disorders compared to gastric emptying scintigraphy.
• Defining and phenotyping gastric abnormalities in long-term type 1 diabetes using a novel body surface gastric mapping device.

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Open-label, single site, prospective, proof of concept evaluation of the effect of liraglutide, a NZ-approved daily injectableGLP-1 agonist, on Gastric Alimetry (GA) outputs in up to 20 healthy volunteers. GA will be performed at baseline, after a 12-14 day ascending dose of liraglutide, and after a minimum 5 day washout period. This approach directly compares GA within subjects with a gastric-focused pharmacological intervention compared to baseline and after a washout phase. The primary endpoint is a change in GA-RI which isa metric used to define gastric dysrhythmia which is seen in disease states such as neuromuscular disorders and gastroparesis. Since there is no reference standard for GA to compare to, this study will instead allow fulfilment of key plausibility criteria for measuring GA in disease (i.e. inducing symptoms and GA changes in healthy subjects with no previous symptoms.) It will also show that the effects are reversible after stopping the medication.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: May 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)