GastroparesisNCT06500130
Effects of Liraglutide on Body Surface Gastric Mapping
A study testing Body Surface Gastric Mapping in people with Gastroparesis and Functional Dyspepsia, run by Alimetry at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Functional Dyspepsia, Chronic Nausea and Vomiting Syndrome
- What is being tested?
- Body Surface Gastric Mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNew Zealand
- Study dates
- 30 May 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Body Surface Gastric Mapping
- Keywords
- Liraglutide, GLP-1 Receptor Agonist, Gastric Motility, Body Surface Gastric Mapping, Gastric Emptying Breath Test
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Surface Gastric MappingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Body Surface Gastric Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 2 weeks
Change in GA-RI on treatment to washout
Change in GA-RI on treatment to washout
Measured: 1 week
Change in BMI-adjusted amplitude on treatment to washout
Change in BMI-adjusted amplitude on treatment to washout
Measured: 1 week
Correlation of total symptom burden with change in GA-RI
Correlation of total symptom burden with change in GA-RI
Measured: 4 weeks
Correlation of total symptom burden with change in BMI-adjusted amplitude
Correlation of total symptom burden with change in BMI-adjusted amplitude
Measured: 4 weeks
Change in gastric emptying half-time on treatment compared to baseline
Change in gastric emptying half-time on treatment compared to baseline
Measured: 2 weeks
Correlation of gastric emptying half-time with GA-RI on treatment
Correlation of gastric emptying half-time with GA-RI on treatment
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start30 May 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimetry
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500130
- Sponsor's protocol ID
- 2024 FULL 19945
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liraglutide on Body Surface Gastric Mapping
- ClinicalTrials.gov ID
- NCT06500130
- Acronym / sponsor ID
- 2024 FULL 19945
- Keywords
- Liraglutide, GLP-1 Receptor Agonist, Gastric Motility, Body Surface Gastric Mapping, Gastric Emptying Breath Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AlimetryIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liraglutide Group | Experimental | Device: Body Surface Gastric MappingAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Surface Gastric MappingAll 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. | Device | Liraglutide Group |
Primary outcome
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.
Time frame: 2 weeks
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline.
9 secondary outcomes
Change in the following symptoms on treatment compared to baseline
Time frame: 2 weeks
Change in overall postprandial BMI-adjusted amplitude on treatment compared to baseline
Time frame: 2 weeks
Change in GA-RI on treatment to washout
Time frame: 1 week
Change in BMI-adjusted amplitude on treatment to washout
Time frame: 1 week
Correlation of total symptom burden with change in GA-RI
Time frame: 4 weeks
Correlation of total symptom burden with change in BMI-adjusted amplitude
Time frame: 4 weeks
Change in gastric emptying half-time on treatment compared to baseline
Time frame: 2 weeks
Correlation of gastric emptying half-time with GA-RI on treatment
Time frame: 2 weeks
Correlation of gastric emptying half-time with total symptom burden on treatment
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Gastric Alimetry® expands patient phenotyping in gastroduodenal disorders compared to gastric emptying scintigraphy.Link provided by the sponsor.
- Defining and phenotyping gastric abnormalities in long-term type 1 diabetes using a novel body surface gastric mapping device.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Surface Gastric Mapping in people with Gastroparesis and Functional Dyspepsia, run by Alimetry at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (GA-RI) on treatment compared to baseline. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.