Semaglutide-Induced Gastric MotilityNCT06401746

Body Surface Gastric Mapping in Patients on Semaglutide

An observational study of Semaglutide-Induced Gastric Motility and Gastroparesis, run by University of Western Sydney at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Semaglutide-Induced Gastric Motility, Gastroparesis
What is being tested?: Gastric Alimetry
Type of treatment: Medical device
How many people: 9 participants
Where: 1 siteAustralia
Study dates: 1 May 2024to 1 Jun 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with or without Type 2 Diabetes Mellitus who are prescribed Semaglutide in a general metabolic clinic.

Who may be able to join

>18 years old
No gastrointestinal symptoms based on Rome IV criteria
For diabetics: Diagnosed T2DM (defined as HbA1c levels > 7%)
For diabetics: Fasting blood glucose level < 15 mmol/L

Who cannot join

Current use of Ozempic, similar GLP-1 RAs or regular insulin in the last 3 months
Confirmed gastroparesis on gastric emptying scintigraphy
Pregnant or breast-feeding
Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Western Sydney University
Campbelltown, New South Wales, 2560

Other trials in Australia

About this study

Official title: Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)

Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use.

This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.

Conditions: Semaglutide-Induced Gastric Motility, Gastroparesis
Being tested: Gastric Alimetry
Keywords: Semaglutide, GLP-1 Receptor Agonist, Gastric Motility, Body Surface Gastric Mapping
Medical subject headings: Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gastric AlimetryDevice
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Study groups in NCT06401746
Study group	Role	What they receive
Semaglutide		Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide. Receives: Device: Gastric Alimetry

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.
Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0.
Measured: Baseline, Month 2 (On Drug)

Secondary outcomes (8)

Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.
The BSGM Principal Gastric Frequency is the number of slow waves in a minute and measured as cycles per minute (cpm). It has a normative reference range between 2.65-3.35 cpm; values outside this range indicate a worse outcome. Minimum: 0; maximum: 6.
Measured: Baseline, Month 2 (On Drug)
Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.
BSGM Gastric Alimetry Rhythm Index is a measure of stability; calculated as a single unitless value. A normal value is indicated as more than or equal to 0.25; a lower value indicates greater instability/worse outcomes. Minimum: 0; maximum: 1.
Measured: Baseline, Month 2 (On Drug)
Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.
Fed:fasted amplitude ratio is the ratio of the maximum 1-hour averaged postprandial amplitude to the premeal average amplitude and calculated as a single value. A normal value is indicated as >1.08; a higher value indicates a better outcome. Minimum: 0.
Measured: Baseline, Month 2 (On Drug)
Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.
Meal response ratio is the ratio of the average amplitude in the first 2 hours postprandially to that of the last 2 hours and calculated as a single value. A normal meal response ratio is defined as > 1; a higher value indicates a better outcome. Minimum: 0.
Measured: Baseline, Month 2 (On Drug)
Change in Total Symptom Burden Score on Drug Compared to Baseline.
Minimum: 0; maximum: 70. A total symptom burden score is calculated by the sum of the mean of each symptom score. A higher score indicates a worse outcome.
Measured: Baseline, 2 Months (On Drug)
Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.
Minimum: 0; maximum: 5. The total GCSI score cover three subscales: nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), and bloating (2 items); calculated by taking the mean of the three individual subscale scores. A higher score indicates a worse outcome.
Measured: Baseline, 2 Months (On Drug)
Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.
Minimum: 0; maximum: 5. The total PAGI-SYM score covers six subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items); calculated by taking the mean of the six individual subscale scores. A higher score indicates a worse outcome.
Measured: Baseline, 2 Months (On Drug)
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Fullness/Early Satiation Subscale on Drug Compared to Baseline.
Minimum: 0; maximum: 5. The PAGI-SYM fullness/early satiation subscale covers post-prandial fullness/early satiety (4 items); calculated by taking the mean of the 4 items. A higher score indicates a worse outcome.
Measured: Baseline, 2 Months (On Drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20241 Jun 2025

First posted7 May 2024
Study start1 May 2024
Primary completion13 Mar 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Semaglutide-Induced Gastric MotilityStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06401746
Sponsor's protocol ID: WS-GLP-001
Status last verified: Aug 2026
First submitted: 28 Apr 2024
Last updated: 31 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
PubMed 36130019
Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
PubMed 37782524
Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
PubMed 36534985
Abraham R, Foong D, Piya M, Grudzinskas K, Ho V. Semaglutide Induces Changes in Gastric Electrical Activity in Patients With Overweight and Obesity: A Pilot Study. J Neurogastroenterol Motil. 2026 Apr 30;32(2):237-243. doi: 10.5056/jnm25156.
PubMed 41952406

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
ClinicalTrials.gov ID: NCT06401746
Acronym / sponsor ID: WS-GLP-001
Conditions: Semaglutide-Induced Gastric Motility, Gastroparesis
Keywords: Semaglutide, GLP-1 Receptor Agonist, Gastric Motility, Body Surface Gastric Mapping
Study type: Observational
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of Western SydneyUniversity, hospital or other
Collaborators: University of Auckland, New Zealand
Study start: 1 May 2024 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 7 May 2024 (actual)
Results: Posted 31 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Semaglutide	–	Device: Gastric AlimetryPatients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with or without Type 2 Diabetes Mellitus who are prescribed Semaglutide in a general metabolic clinic.

Key inclusion criteria (4 listed)

>18 years old
No gastrointestinal symptoms based on Rome IV criteria
For diabetics: Diagnosed T2DM (defined as HbA1c levels > 7%)
For diabetics: Fasting blood glucose level < 15 mmol/L

Key exclusion criteria (4 listed)

Current use of Ozempic, similar GLP-1 RAs or regular insulin in the last 3 months
Confirmed gastroparesis on gastric emptying scintigraphy
Pregnant or breast-feeding
Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

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
Gastric AlimetryThe Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.	Device	Semaglutide

Primary outcome

Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.
Time frame: Baseline, Month 2 (On Drug)
Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0.

8 secondary outcomes

Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.
Time frame: Baseline, Month 2 (On Drug)
Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.
Time frame: Baseline, Month 2 (On Drug)
Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.
Time frame: Baseline, Month 2 (On Drug)
Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.
Time frame: Baseline, Month 2 (On Drug)
Change in Total Symptom Burden Score on Drug Compared to Baseline.
Time frame: Baseline, 2 Months (On Drug)
Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.
Time frame: Baseline, 2 Months (On Drug)
Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.
Time frame: Baseline, 2 Months (On Drug)
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Fullness/Early Satiation Subscale on Drug Compared to Baseline.
Time frame: Baseline, 2 Months (On Drug)

Results and safety

Results posted to the registry on 31 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide	9	8

Primary outcome: Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.

Time frame: Baseline, Month 2 (On Drug). Mean (Standard Deviation). Unit: microvolts

Measure	Semaglutide n = 8
Baseline	37.05 (8.14)
On Drug	32.94 (5.42)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until study completion, up to 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36130019Gharibans AA, Calder S, Varghese C, Waite S, Schamberg G, Daker C, Du P, Alighaleh S, Carson D, Woodhead J, Farrugia G, Windsor JA, Andrews CN, O'Grady G. Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. Sci Transl Med. 2022 Sep 21;14(663):eabq3544. doi: 10.1126/scitranslmed.abq3544. Epub 2022 Sep 21.
Background: PubMed 37782524Wang WJ, Foong D, Calder S, Schamberg G, Varghese C, Tack J, Xu W, Daker C, Carson D, Waite S, Hayes T, Du P, Abell TL, Parkman HP, Huang IH, Fernandes V, Andrews CN, Gharibans AA, Ho V, O'Grady G. Gastric Alimetry Expands Patient Phenotyping in Gastroduodenal Disorders Compared with Gastric Emptying Scintigraphy. Am J Gastroenterol. 2024 Feb 1;119(2):331-341. doi: 10.14309/ajg.0000000000002528. Epub 2023 Oct 30.
Background: PubMed 36534985Varghese C, Schamberg G, Calder S, Waite S, Carson D, Foong D, Wang WJ, Ho V, Woodhead J, Daker C, Xu W, Du P, Abell TL, Parkman HP, Tack J, Andrews CN, O'Grady G, Gharibans AA. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2023 Jun 1;118(6):1047-1057. doi: 10.14309/ajg.0000000000002077. Epub 2022 Dec 20.
Results publication: PubMed 41952406Abraham R, Foong D, Piya M, Grudzinskas K, Ho V. Semaglutide Induces Changes in Gastric Electrical Activity in Patients With Overweight and Obesity: A Pilot Study. J Neurogastroenterol Motil. 2026 Apr 30;32(2):237-243. doi: 10.5056/jnm25156.
Individual participant dataSharing planned: No

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.

Vincent Ho, MBBS, FRACP, FACP, PhD principal investigator

Western Sydney University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Semaglutide-Induced Gastric Motility and Gastroparesis, run by University of Western Sydney at 1 site in Australia.

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 4 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 31 Aug 2026. 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 Australia. 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?

Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 BSGM BMI-adjusted Amplitude on Drug Compared to Baseline. (time frame: Baseline, Month 2 (On Drug)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401746, which also lists 4 linked publications.

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 31 Aug 2026.