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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Body Surface Gastric Mapping in Patients on Semaglutide

NCTNCT06401746 (opens ClinicalTrials.gov in a new tab)Other idWS-GLP-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
9 participants (actual)
Sponsor
University of Western Sydney · Other
Design
Not stated
Countries
1 country

Australia

Start
1 May 2024
Primary completion
13 Mar 2025
Completion
1 Jun 2025
First posted
7 May 2024
Last update posted
31 Aug 2026
Conditions
Semaglutide-Induced Gastric Motility · Gastroparesis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph –

    Body Surface Gastric Mapping in Patients on Semaglutide

    NCT06401746

    1 May 2024 to 1 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects. 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.

Interventions

  • Gastric AlimetryDevice

Arms1

  • Other

    Semaglutide

    Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.

    Time frame · Baseline, Month 2 (On Drug)

    Registry description

    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.

Secondary outcomes(8)

  1. Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.

    Time frame · Baseline, Month 2 (On Drug)

    Registry description

    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.

  2. Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.

    Time frame · Baseline, Month 2 (On Drug)

    Registry description

    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.

  3. Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.

    Time frame · Baseline, Month 2 (On Drug)

    Registry description

    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.

  4. Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.

    Time frame · Baseline, Month 2 (On Drug)

    Registry description

    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.

  5. Change in Total Symptom Burden Score on Drug Compared to Baseline.

    Time frame · Baseline, 2 Months (On Drug)

    Registry description

    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.

  6. Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.

    Time frame · Baseline, 2 Months (On Drug)

    Registry description

    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.

  7. 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)

    Registry description

    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.

  8. 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)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Month 2 (On Drug)

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

GroupValue (microvolts)Spread
Semaglutide37.058.14
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Month 2 (On Drug)

Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.

GroupValue (cycles per minute (cpm))Spread
Semaglutide3.000.10
Secondary outcomeMean· Baseline, Month 2 (On Drug)

Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.

GroupValue (Index)Spread
Semaglutide0.570.24
Secondary outcomeMean· Baseline, Month 2 (On Drug)

Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.

GroupValue (Ratio)Spread
Semaglutide2.081.06
Secondary outcomeMean· Baseline, Month 2 (On Drug)

Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.

GroupValue (Ratio)Spread
Semaglutide1.420.89
Secondary outcomeMean· Baseline, 2 Months (On Drug)

Change in Total Symptom Burden Score on Drug Compared to Baseline.

GroupValue (Score on a scale)Spread
Semaglutide6.255.44
Secondary outcomeMean· Baseline, 2 Months (On Drug)

Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.

GroupValue (Scores on a scale)Spread
Semaglutide0.630.54
Secondary outcomeMean· Baseline, 2 Months (On Drug)

Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.

GroupValue (Scores on a scale)Spread
Semaglutide0.700.68

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutidePatients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.0 / 80 / 80 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2026

Semaglutide Induces Changes in Gastric Electrical Activity in Patients With Overweight and Obesity: A Pilot Study.

Abraham et al. 2026Journal of neurogastroenterology and motility

PMID 41952406PMC13076063DOI 10.5056/jnm25156PUB-41952406

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * \>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 Exclusion Criteria: * 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.

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