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RECRUITINGEarly Phase 1INTERVENTIONAL

Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Mounjaro

In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide after surgery. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.

PROCEDURE

Sleeve Gastrectomy

Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.

Locations (1)

Rush University Medical Center
Chicago, Illinois, United States