Trials Sponsors Conditions Drugs Pricing

Conditions

Obese Adults

Keywords

ObesityGLP-1tirzepatideGERDpH testingEGDManometry

Outcome Measures

Primary Outcomes (1)

Total Esophageal Acid Exposure Time During 96-Hour Wireless pH Monitoring
Percentage of total analyzable wireless pH recording time during which distal esophageal pH is less than 4. The value is calculated as the total duration with pH less than 4 divided by the total analyzable recording duration, multiplied by 100. One overall percentage is calculated for each participant across the monitoring period. Higher percentages indicate greater esophageal acid exposure.
During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.

Secondary Outcomes (11)

Number of Days With Abnormal Esophageal Acid Exposure During 96-Hour Wireless pH Monitoring
During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Composite DeMeester Score During Wireless pH Monitoring
During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Esophagogastric Junction Distensibility Index Measured by Functional Lumen Imaging Probe
At the functional lumen imaging probe assessment, performed within 40 days after enrollment.
Maximum Esophagogastric Junction Diameter Measured by Functional Lumen Imaging Probe
At the functional lumen imaging probe assessment, performed within 40 days after enrollment.
Resting Lower Esophageal Sphincter Pressure Measured by High-Resolution Manometry
At the high-resolution manometry assessment, performed within 40 days after enrollment.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Once subcutaneous injection

Drug: Placebo

Tirzepatide

ACTIVE COMPARATOR

Tirzepatide 7.5 mg subcutaneous injection

Drug: Tirzepatide

Interventions

PlaceboDrug

Placebo subcutaneously once

Placebo

TirzepatideDrug

tirzepatide 7.5 mg subcutaneously once

Also known as: Zepbound

Tirzepatide

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent form with HIPAA authorization
Male or female, ages 18-75 inclusive.

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Lizeth Cifuentes, MDCONTACT507-284-2511 CIFUENTES.ADRIANA@MAYO.EDU

Karthik Ravi, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

ObesityGastroesophageal Reflux

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal Diseases

Study Officials

Karthik Ravi, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizeth Cifuentes, MD

CONTACT

507-284-2511 cifuentes.adriana@mayo.edu

Sanna McKinzie, MS

CONTACT

507-284-2511

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Concealed allocation with masking of medications administered by subcutaneous injection once; blinding of all investigators since medication is dispensed by research pharmacy.
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 26, 2026

Study Start

October 26, 2026

You may not qualify if:

Pregnancy or breastfeeding. A point of care urine pregnancy test will be performed within 48 hours of receipt of the study medication for all women of childbearing potential. Women who are postmenopausal times 1 year, post tubal ligation or post hysterectomy are exempt from pregnancy tests.
Diagnosis of type 1 or type 2 diabetes regardless of current treatment, because diabetes and its therapies may affect gastrointestinal physiology and may alter the safety profile of tirzepatide in this acute mechanistic study.
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type II.
Known serious allergic reaction to components of tirzepatide, midazolam or topical lidocaine.
Treatment with an investigational drug/intervention within 30 days or five half-lives of the study medication, whichever is longer.
Chronic systemic or GI diseases that could affect GI motility, appetite or absorption (e.g., IBD, significant neurologic disease, advanced renal/hepatic/cardiopulmonary disease), or active peptic ulcer disease
Previously documented structural esophageal disease including hiatal hernia \>3 cm, esophageal stricture, prior LA Grade B-D erosive esophagitis, or biopsy-proven Barrett's esophagus.
Previously diagnosed major esophageal motility disorder based on Chicago Classification v4.0 including achalasia, esophagogastric junction outflow obstruction, absent contractility, distal esophageal spasm or hypercontractile esophagus.
Mechanical obstruction, bleeding diathesis, esophageal varices, severe esophagitis, or another anatomic or clinical condition that would preclude safe placement of study devices, including the manometry catheter, Endo FLIP catheter, or Bravo pH capsule.
Pacemaker or implanted cardiac defibrillator. Other implanted electronic devices will be reviewed by the study physician for compatibility with the Bravo system.
Planned or reasonably anticipated MRI within 30 days after Bravo capsule placement, or inability to comply with the 30-day MRI restriction.
Known gastroparesis or previously documented delayed gastric emptying based on a clinically indicated gastric emptying test.
History of pancreatitis, active or recent symptomatic gallbladder disease, including symptomatic cholelithiasis or cholecystitis, alcohol use disorder, or triglycerides \>500 mg/dL
Significant untreated GERD based on screening with the GERD HRQL questionnaire. If participant has any total score ≥ 20 on questions 1-10, the participant will be interviewed by a study physician. If participant is excluded from the study, s/he will be referred to their primary care physician.
Use of acid-suppressive medication that cannot be discontinued for at least 14 days before Bravo capsule placement and withheld through completion of the 96-hour recording, unless resumed for clinical necessity.
+89 more criteria

Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Placebo

Tirzepatide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Placebo

Tirzepatide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations