Obese AdultsPhase 4NCT07893457
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
A Phase 4 study testing Tirzepatide in people with Obese Adults, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese Adults
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to 26 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form with HIPAA authorization
- Male or female, ages 18-75 inclusive.
- Obesity/overweight as per FDA weight-management indication for tirzepatide (Zepbound®): defined as BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with ≥ 1 weight-related comorbidity such as hypertension, dyslipidemia, OSA or CVD and < 45 kg/m2.
- Able to travel to Mayo Clinic for all required in-person study visits..
- In good general health with no untreated, clinically significant cardiac, pulmonary, gastrointestinal, hepatic renal, hematologic, neurologic, psychiatric or endocrine disorder.
- Women of childbearing potential must have a negative pregnancy test result within 48 hours of administration of study medication. They must agree to use a highly effective method of contraception through 4 weeks after the single dose of study medication. Because tirzepatide may reduce the bioavailability of oral hormonal contraceptives, women who are using oral hormonal contraceptives must also use an additional barrier method of contraception during this time. Women who are postmenopausal times 1 year, post tubal ligation or post hysterectomy are exempt from pregnancy tests.
Show all 9Show fewer
- No increase or decrease in body weight > 5% during the 3 months before study entry.
- No GLP-1 receptor agonist or dual incretin medication during the 3 months before study entry.
- Agree to adhere to diet instructions prior to EGD and manometry.
Who cannot join
- 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.
- History of abdominal surgery other than appendectomy, cholecystectomy, tubal ligation or cesarian section. Bariatric surgery and anti-reflux surgery including fundoplication or LINX are exclusions.
Show all 106Show fewer
- 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.
- Known clinically significant or severe hypersensitivity to stainless steel or metals in the Bravo capsule delivery system, including nickel, chromium, copper, cobalt, or iron, when the study physician determines that the capsule placement would pose an unacceptable risk. A history of a nonspecific or mild metal sensitivity is not an exclusion.
- 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.
- Disallowed concomitant medications due to effects on stomach or appetite:
- Resin sequestrants for hyperlipidemia
- Cholestyramine (Questran®)
- Colesevelam (WelChol®)
- Colestipol (Colestid®)
- α2-agonists for hypertension
- Clonidine (Catapres®)
- Methyldopa
- Guanfacine (Intuniv®)
- 5HT3 receptor antagonists
- Ondansetron (Zofran®)
- Granisetron (Kytril®)
- Palonosetron (Posfrea®)
- NK-1 receptor antagonists
- Aprepitant (Emend®)
- Fosaprepitant (Focinvez®)
- Rolapitant (Varubi®)
- Dopamine receptor antagonists / prokinetics
- Metoclopramide (Reglan®)
- Domperidone (Motilium®)
- Prochlorperazine (Compazine®)
- Haloperidol (Haldol®)
- Anticholinergics
- Scopolamine (Transderm Scop®)
- Dicyclomine (Bentyl®)
- Hyoscyamine (Levsin®)
- Corticosteroids
- Dexamethasone (Decadron®)
- Methylprednisolone (Medrol®)
- Antipsychotics
- Olanzapine (Zyprexa®)
- Quetiapine (Seroquel®)
- Opioids
- Tramadol (Ultram®)
- Morphine (MS Contin®)
- Oxycodone (OxyContin®)
- Fentanyl
- Hydromorphone (Dilaudid®)
- Codeine
- Methadone
- Cannabinoids and cannabinoid products
- THC
- CBD
- Dronabinol
- Nabilone
- Tricyclic antidepressants
- Nortriptyline (Pamelor®)
- Amitriptyline (Elavil®)
- Doxepin (Silenor®)
- Desipramine (Norpramin®)
- Imipramine (Tofranil®)
- Prokinetics
- Tegaserod (Zelnorm®)
- Pyridostigmine (Regonol®) Prucalopride (Motegrity®)
- Selective serotonin and norepinephrine reuptake inhibitors
- Venlafaxine (Effexor®)
- Duloxetine (Cymbalta®)
- Desvenlafaxine (Pristiq®)
- Note: Selective serotonin reuptake inhibitors are acceptable provided that the dose has been stable prior to study for 30 days.
- Fluoxetine (Prozac®)
- Citalopram (Celexa®)
- Escitalopram (Lexapro®)
- Paroxetine (Paxil®)
- Sertraline (Zoloft®)
- Selective norepinephrine reuptake inhibitors
- Atomoxetine (Strattera®)
- Viloxazine (Qelbree®)
- Note: Bupropion (Wellbutrin®)is acceptable provided that the dose has been stable prior to study for 30 days.
- Other weight loss medications
- Bupropion with naltrexone
- Phentermine with or without topiramate
- ADHD medications
- Methylphenidate (Ritalin® or Concerta®)
- Dextroamphetamine (Adderall®)
- Lisdexamfetamine (Vyvanse®)
- Mirtazapine and buspirone (Buspar®)
- Sulfonylureas
- Glimepiride (Amaryl®)
- Glipizide (Glucatrol®)
- Glyburide (Diabeta®)
- DPP-4 inhibitors
- Sitagliptin (Januvia
- Vildagliptin (Galvus®)
- Linagliptin (Tradjenta®)
- Alogliptin (Nesina®)
- Metformin, acarbose and insulin
- Amylin agonists/analogs
- Pramlintide (Symlin®)
- Cyclobenzaprine (Flexeril®)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Rochester, Minnesota, 55905
Lizeth Cifuentes, MD, 507-284-2511, CIFUENTES.ADRIANA@MAYO.EDU
Karthik Ravi, MD
About this study
Official title: Acute Effects of a Single Dose of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
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.
Read the detailed description
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.
- Conditions
- Obese Adults
- Being tested
- Placebo, Tirzepatide
- Keywords
- Obesity, GLP-1, tirzepatide, GERD, pH testing, EGD, Manometry
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo subcutaneously once
TirzepatideDrug
Also called Zepbound
tirzepatide 7.5 mg subcutaneously once
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Once subcutaneous injection Receives: Drug: Placebo |
| Tirzepatide | Active comparator | Tirzepatide 7.5 mg subcutaneous injection Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion26 Oct 2027 (estimated)
- Study completion26 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind, placebo-controlled trial examining the acute effects of tirzepatide versus placebo on increase total esophageal acid exposure during a 96-hour wireless pH recording.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Ravi, M.D., Mayo Clinic
- Investigators
- Karthik Ravi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893457
- Sponsor's protocol ID
- 26-004965
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Single Center Study
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Single Dose of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
- ClinicalTrials.gov ID
- NCT07893457
- Acronym / sponsor ID
- 26-004965
- Conditions
- Obese Adults
- Keywords
- Obesity, GLP-1, tirzepatide, GERD, pH testing, EGD, Manometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 26 Oct 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, placebo-controlled trial examining the acute effects of tirzepatide versus placebo on increase total esophageal acid exposure during a 96-hour wireless pH recording.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOnce subcutaneous injection |
| Tirzepatide | Active comparator | Drug: TirzepatideTirzepatide 7.5 mg subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form with HIPAA authorization
- Male or female, ages 18-75 inclusive.
- Obesity/overweight as per FDA weight-management indication for tirzepatide (Zepbound®): defined as BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with ≥ 1 weight-related comorbidity such as hypertension, dyslipidemia, OSA or CVD and < 45 kg/m2.
- Able to travel to Mayo Clinic for all required in-person study visits..
- In good general health with no untreated, clinically significant cardiac, pulmonary, gastrointestinal, hepatic renal, hematologic, neurologic, psychiatric or endocrine disorder.
Key exclusion criteria (106 listed)
- 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.
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 |
|---|---|---|
| PlaceboPlacebo subcutaneously once | Drug | Placebo |
| TirzepatideAlso: Zepboundtirzepatide 7.5 mg subcutaneously once | Drug | Tirzepatide |
Primary outcome
Total Esophageal Acid Exposure Time During 96-Hour Wireless pH Monitoring
Time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
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.
11 secondary outcomes
Number of Days With Abnormal Esophageal Acid Exposure During 96-Hour Wireless pH Monitoring
Time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.
Composite DeMeester Score During Wireless pH Monitoring
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
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
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
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Integrated Relaxation Pressure Measured by High-Resolution Manometry
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Mean Proximal Intragastric Pressure Before Seated Swallows
Time frame: At the high-resolution manometry assessment, performed within 40 days after enrollment.
Mean Proximal Intragastric Pressure During Swallow-Induced Esophagogastric Junction Opening
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
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
Time frame: Baseline and Day 7.
Change From Baseline to Day 7 in Brief Esophageal Dysphagia Questionnaire Total Score
Time frame: Baseline and Day 7.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Single Center Study
Related trials for Obese Adults
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 3
A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM)
Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
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.
Karthik Ravi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Obese Adults, run by Mayo Clinic at 1 site in United States.
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 9 inclusion and 106 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: opening soon, as of the sponsor's last update on 26 Oct 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizeth Cifuentes, MD (507-284-2511, cifuentes.adriana@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Esophageal Acid Exposure Time During 96-Hour Wireless pH Monitoring (time frame: During the 96-hour wireless pH monitoring period, completed within 40 days after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.