Effects of Liraglutide on Body Surface Gastric Mapping

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Functional Dyspepsia; Gastroparesis; Chronic Nausea and Vomiting Syndrome
• Intervention / Treatment: Device: Body Surface Gastric Mapping

Detailed Description

Globally, more than 40% of persons have a functional gastrointestinal(GI) disorder based on the Rome IV diagnostic questionnaire. These disorders encompass gastroparesis and chronic nausea and vomiting syndromes (CNVS; including chronic unexplained nausea and vomiting(CNV) and cyclic vomiting syndrome (CVS)), functional dyspepsia (FD; chronic indigestion), and post-operative gastric dysfunction. The disorders are linked by the fact that no obvious structural cause for their symptoms can be identified, based on investigations such as endoscopy or imaging. However, there is still a lack of diagnostic biomarkers for these functional disorders. Measuring gastric emptying rate with either scintigraphy or a breath test is the only clinically used test of gastric function; if abnormal the patient is listed as having gastroparesis. However, this test fails to clearly explain the symptom pattern and severity, does not predict response to therapy and changes in the test result do not correlate with evolution of clinical symptoms. There is also substantial crossover in symptoms between functional dyspepsia and gastro-esophageal reflux disease, and differentiating these condition scan be challenging.

GLP-1 analogues cause GI distress and weight loss due to their effect on slowing gastric emptying, inducing satiety or loss of appetite, and thus reducing oral intake. GI symptoms such as nausea, similar to symptoms of gastroparesis, are the most common reason for discontinuation of these drugs. Gastric Alimetry (GA) is a new device which measures gastric electrophysiology. We postulate that GA will show changes in gastric spectral analysis as well as symptoms in healthy volunteers on a once daily injectable GLP-1 analogue, liraglutide.

References:

Sperber AD, Bangdiwala SI, Drossman DA, Ghoshal UC, Simren M, TackJ, Whitehead WE, Dumitrascu DL, Fang X, Fukudo S, Kellow J.Worldwide prevalence and burden of functional gastrointestinaldisorders, results of Rome Foundation Global Study.

Gastroenterology. 2021;160(1):99-114 Pasricha PJ, Grover M, Yates KP,Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, BulatR, Chen J. Functional dyspepsia and gastroparesis in tertiary care areinterchangeable syndromes with common clinical and pathologicfeatures. Gastroenterology. 2021;160(6):2006-17 Parkman, Henry P.,Daniel S. Rim, Jonathan R. Anolik, Simin Dadparvar, and Alan H. Maurer.2024. "Glucagonlike Peptide-1 Receptor Agonists: The Good, the Bad,and the Ugly-Benefits for Glucose Control and Weight Loss with SideEffects of Delaying Gastric Emptying." Journal of Nuclear MedicineTechnology, January. https://doi.org/10.2967/jnmt.123.266800.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1010
    • Alimetry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

1. Confirmed diagnosis of a comorbidity known to affect gastric motility (i.e., Parkinson's Disease, Type 1 or 2 Diabetes).
2. Medications in the last 3 months known to impact gastric motility.
3. Any Gastric Surgery
4. Pregnancy or lactation, determined by pregnancy test at timeof enrolment.
5. 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
6. Use of GLP-1 agonist and/or on regular insulin in the past 3months.
7. 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).
8. History of peptic ulcer, pancreatitis, cholelithiasis, choledocholithiasis, History of kidney or hepatic dysfunction
9. History of psychiatric disturbance requiring medication in the year before enrolment, any history of suicide attempt or eating disorder
10. History of Type II Diabetes or glucose intolerance (treated or untreated)
11. 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)
12. History of angioedema or urticaria disorder
13. History of cardiac disorder or arrhythmia
14. Any tobacco, vaping or cannabinoid use in the 30 days prior to study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the following symptoms on treatment compared to baseline	GCSI-DD (3 day average, last 3 days on treatment vs 3 days baseline) Alimetry total symptom burden Alimetry individual symptoms	2 weeks
Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline	Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline	2 weeks
Change in GA-RI on treatment to washout	Change in GA-RI on treatment to washout	1 week
Change in BMI-adjusted amplitude on treatment to washout	Change in BMI-adjusted amplitude on treatment to washout	1 week
Correlation of total symptom burden with change in GA-RI	Correlation of total symptom burden with change in GA-RI	4 weeks
Correlation of total symptom burden with change in BMI-adjusted amplitude	Correlation of total symptom burden with change in BMI-adjusted amplitude	4 weeks
Change in gastric emptying half-time on treatment compared to baseline	Change in gastric emptying half-time on treatment compared to baseline	2 weeks
Correlation of gastric emptying half-time with GA-RI on treatment	Correlation of gastric emptying half-time with GA-RI on treatment	2 weeks
Correlation of gastric emptying half-time with total symptom burden on treatment	Correlation of gastric emptying half-time with total symptom burden on treatment	2 weeks

Collaborators and Investigators

• Sponsor: Alimetry

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Liraglutide; Gastric Emptying Breath Test; Gastric Motility; GLP-1 Receptor Agonist; Body Surface Gastric Mapping
• Additional Relevant MeSH Terms: Neurologic Manifestations; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Vomiting; Dyspepsia; Gastroparesis
• Other Study ID Numbers: 2024 FULL 19945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No