Tirzepatide for Obesity

LC
SM
Overseen BySanna McKinzie, MS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KR

Karthik Ravi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with obesity who may also have acid reflux (GERD). Participants should not have other major health issues that could interfere with the study or its results.

Inclusion Criteria

Signed and dated informed consent form with HIPAA authorization
Agree to adhere to diet instructions prior to EGD and manometry
Obesity/overweight as per FDA weight-management indication for tirzepatide (Zepbound®): 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
See 6 more

Exclusion Criteria

Known serious allergic reaction to tirzepatide, midazolam or topical lidocaine components
I have been diagnosed with a major esophageal motility disorder.
I have been diagnosed with delayed stomach emptying or gastroparesis.
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study compares a single injection of tirzepatide to a placebo (saltwater) to see if tirzepatide affects stomach and esophagus function, especially acid exposure, over several days.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: TirzepatideActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+