Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation

NCT07784127 | Not Yet Recruiting

• 1 other identifier: 26-115
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will undergo evaluation with the Atmo capsule at two time points: at baseline before starting the GLP-1RA or dual agonist therapy and after the subject has been taking their GLP-1RA or dual agonist therapy for 3 months. The total expected time for patient participation is up to 4 months from the time they start their GLP-1RA or dual agonist therapy.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire

  At Baseline and 3 Month Follow Up

• Patient-Reported Severity and Frequency of Gastrointestinal Symptoms as Assessed by Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire

  At Baseline and 3 Month Follow Up

• Patient-Reported frequency, duration, and diagnostic criteria for conditions affecting the gastrointestinal tract for colonic motility and function as Assessed by Rome IV Diagnostic Questionnaire

  At Baseline and 3 Month Follow Up

Study Arms (1)

Participants initiating GLP-1RA therapy

EXPERIMENTAL

Participants starting the GLP-1RA or dual agonist therapy and taking their GLP-1RA or dual agonist therapy for 3 months.

Procedure: Gut motility quantification using a capsule after initiating GLP-1RA therapy

Interventions

Gut motility quantification using a capsule after initiating GLP-1RA therapy PROCEDURE

Participants will undergo evaluation with the Atmo capsule at two time points: at baseline before starting the GLP-1RA or dual agonist therapy and after the subject has been taking their GLP-1RA or dual agonist therapy for 3 months. The total expected time for patient participation is up to 4 months from the time they start their GLP-1RA or dual agonist therapy.

Participants initiating GLP-1RA therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years or older)
• Initiating GLP-1RA or GLP-1RA/GIP (dual agonist) therapy, or off GLP-1RA or GLP1-RA/GIP therapy for greater than 3 months for the treatment of type 2 diabetes with or without obesity (BMI \> 30 kg/m2) at the time of the baseline visit
• Stable glucose control (HbA1c ≤ 9%) within 6 months of the baseline visit
• Normal TSH within 6 months of baseline visit

You may not qualify if:

• Current use of opiates, marijuana, anticholinergics, or pro-motility medications. Can be included if there is no utilization for at least 1 month.
• Use of antibiotics within the past 2 weeks
• History of gastric or bowel surgery
• Known or suspected history or active intestinal obstruction or stricture
• Pregnancy
• Patients for whom English is not their primary language will be excluded.
• Cognitively impaired persons or other vulnerable populations who are unable to provide informed consent will be excluded.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Atmo Biosciences Pty Ltd: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

US (1)