NCT06734273EARLY_PHASE1Recruiting
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Nicholas Skertich
Start Date
3/10/2025
Completion Date
9/1/2028
Summary
This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
Eligibility Criteria
Age Range: 18 years to 65 years
Inclusion Criteria:
* Adult 18 to 65 years of age
* Body Mass Index \>35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index \>40 with or without comorbidity
* Undergoing primary sleeve gastrectomy
Exclusion Criteria:
* Prior metabolic and bariatric surgery
* Prior use of GLP-1 agonist
* Prior history of pancreatitis
* Personal/family history of medullary thyroid cancer or MEN type 2
* Secondary cause of obesity
* Any eating disorder
* Pregnancy/lactation
* History of acute coronary syndrome or myocardial infarction
* History of stroke
* Hepatic dysfunction: AST/ALT \>3 ULN
* Renal dysfunction eGFR\<45ml/min/1.73m2
* Active malignancy
* History of diabetic retinopathy
* History of gastroparesis
Interventions
DRUG
Mounjaro
PROCEDURE
Sleeve Gastrectomy
Conditions
Obesity and Obesity-related Medical Conditions
Locations
Rush University Medical Center
Chicago, Illinois 60612
United States