Mayo Clinic
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-…
Inclusion Criteria: 1. Signed and dated informed consent form with HIPAA authorization 2. Male or female, ages 18-75 inclusive. 3. 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. 4. Able to travel to Mayo Clinic for all required in-person study visits.. 5. In good general health with no untreated, clinically significant cardiac, pulmonary, gastrointestinal, hepatic renal, hematologic, neurologic, psychiatric or…
Placebo subcutaneously once
tirzepatide 7.5 mg subcutaneously once
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