Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Recruiting · NCT06734273 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MounjaroSleeve Gastrectomy
What this trial 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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Rush University Medical Center - Chicago, Illinois, United States