Clinical trial

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

Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT06734273

Recruiting nowEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Obesity-related Medical Conditions

Full registry criteria

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 and study arms

Mounjaro

Drug

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.

Sleeve Gastrectomy

Procedure

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

Primary outcomes

Weight Loss12 months after surgery

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rush University Medical Center🇺🇸 Chicago, Illinois, United States

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Sr. Clinical Research CoordinatorContact

Email · Call 312-942-5500