A Phase 4 interventional study of Placebo and Tirzepatide in Obese Adults, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Basic science
This study will assess whether a single subcutaneous dose of tirzepatide 7.5 mg , compared with saline placebo, increases total esophageal acid exposure time during a 96-hour wireless pH recording beginning about 48 hours after study medication.
In this prospective, randomized, double-blind, placebo-controlled trial, adults aged 18-75 years with overweight or obesity who meet FDA weight-management criteria and do not have diabetes, prior foregut surgery, or use of motility-altering medications will be randomized 1:1 to receive tirzepatide 7.5 mg subcutaneously or saline placebo. Physiologic testing will occur 48 hours after dosing and will include high-resolution esophageal manometry (HRM), esophagogastroduodenoscopy with functional lumen imaging probe (FLIP), mucosal impedance measurement using the MiVu system, and placement of a 96-hour wireless pH capsule (Bravo). HRM will quantify LES pressure, integrated relaxation pressure, esophageal contractility, and proximal intragastric pressure. FLIP will assess EGJ distensibility index and EGJ diameter. Participants will complete GERD-HRQL, BEDQ, and EHAS.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Disallowed concomitant medications due to effects on stomach or appetite:
Resin sequestrants for hyperlipidemia
α2-agonists for hypertension
5HT3 receptor antagonists
NK-1 receptor antagonists
Dopamine receptor antagonists / prokinetics
Anticholinergics
Antipsychotics
Opioids
Cannabinoids and cannabinoid products
Tricyclic antidepressants
Prokinetics
Selective serotonin and norepinephrine reuptake inhibitors
Note: Selective serotonin reuptake inhibitors are acceptable provided that the dose has been stable prior to study for 30 days.
Selective norepinephrine reuptake inhibitors
Note: Bupropion (Wellbutrin®)is acceptable provided that the dose has been stable prior to study for 30 days.
Other weight loss medications
ADHD medications
Sulfonylureas
DPP-4 inhibitors
Amylin agonists/analogs
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once subcutaneous injection
Drug: Placebo
Tirzepatide 7.5 mg subcutaneous injection
Drug: Tirzepatide
Placebo subcutaneously once
tirzepatide 7.5 mg subcutaneously once
Also known as: Zepbound
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.
Time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Number of Days With Abnormal Esophageal Acid Exposure During 96-Hour Wireless pH Monitoring
Number of interpretable 24-hour recording periods during which esophageal acid exposure time is greater than 6%. Acid exposure time is the percentage of analyzable recording time with distal esophageal pH less than 4. The outcome is a single count of abnormal recording days for each participant.
Time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Composite DeMeester Score During Wireless pH Monitoring
Composite DeMeester score calculated from the analyzable wireless esophageal pH recording. This outcome reports a single composite score for each participant. Higher scores indicate greater esophageal acid reflux burden.
Time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Esophagogastric Junction Distensibility Index Measured by Functional Lumen Imaging Probe
Esophagogastric junction distensibility index, expressed in square millimeters per millimeter of mercury (mm²/mmHg), measured using the functional lumen imaging probe at a balloon fill volume of 60 mL when intraballoon pressure is greater than 15 mmHg. Higher values indicate greater esophagogastric junction distensibility.
Time frame: At the functional lumen imaging probe assessment, performed within 40 days after enrollment.
Maximum Esophagogastric Junction Diameter Measured by Functional Lumen Imaging Probe
Maximum esophagogastric junction diameter, expressed in millimeters, measured using the functional lumen imaging probe. The reported value is the larger of the maximum diameters obtained at balloon fill volumes of 60 mL and 70 mL, yielding one maximum diameter for each participant.
Time frame: At the functional lumen imaging probe assessment, performed within 40 days after enrollment.
Resting Lower Esophageal Sphincter Pressure Measured by High-Resolution Manometry
Resting lower esophageal sphincter pressure, expressed in millimeters of mercury (mmHg), measured using high-resolution esophageal manometry.
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Integrated Relaxation Pressure Measured by High-Resolution Manometry
Integrated relaxation pressure, expressed in millimeters of mercury (mmHg), measured during standardized water swallows using high-resolution esophageal manometry.
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Mean Proximal Intragastric Pressure Before Seated Swallows
Mean proximal intragastric pressure during the preswallow interval of seated swallows, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction.
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Mean Proximal Intragastric Pressure During Swallow-Induced Esophagogastric Junction Opening
Mean proximal intragastric pressure during swallow-induced esophagogastric junction opening in the seated position, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction.
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Mean Proximal Intragastric Pressure Immediately After Swallow-Induced Esophagogastric Junction Closure
Mean proximal intragastric pressure immediately after esophagogastric junction closure following seated swallows, expressed in millimeters of mercury (mmHg). Pressure is measured using high-resolution manometry at a location 1 to 3 cm distal to the manometrically identified esophagogastric junction.
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Change From Baseline to Day 7 in Gastroesophageal Reflux Disease Health-Related Quality of Life Total Score
Change in the Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) total score, calculated as the Day 7 score minus the baseline score. The 15 scored items are each rated from 0 to 5 and summed to produce a total score ranging from 0 to 75. Higher total scores indicate greater symptom burden and worse disease-related quality of life. Negative change values indicate reduced symptom burden.
Time frame: Baseline and Day 7.
Change From Baseline to Day 7 in Brief Esophageal Dysphagia Questionnaire Total Score
Change in the Brief Esophageal Dysphagia Questionnaire (BEDQ) total score, calculated as the Day 7 score minus the baseline score. The total is the sum of eight symptom-frequency and symptom-severity items, each scored from 0 to 5, and ranges from 0 to 40. The two food-impaction items are not included in the total score. Higher total scores indicate greater dysphagia symptom burden. Negative change values indicate reduced symptom burden.
Time frame: Baseline and Day 7.
Plan to share: No — Single Center Study
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirzepatide