Combining sleeve gastrectomy with tirzepatide for enhanced weight loss
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
This study tests if adding a weight loss medication called tirzepatide to sleeve gastrectomy surgery can help people lose more weight and improve health issues related to obesity.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06734273 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding tirzepatide, a weight loss medication, to sleeve gastrectomy surgery to maximize weight loss and improve obesity-related conditions such as Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea. Participants will be randomly assigned to receive either the medication in conjunction with surgery or surgery alone. The study will also assess the safety of this combined approach by monitoring for complications and side effects compared to surgery alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a BMI over 35 and comorbidities like Type 2 diabetes or hypertension, or a BMI over 40.
Not a fit: Patients with a history of certain medical conditions, prior metabolic surgery, or specific contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to greater weight loss and improved management of obesity-related health conditions for patients.
How similar studies have performed: While the combination of sleeve gastrectomy and tirzepatide is a novel approach, similar studies have shown promising results with other weight loss medications post-surgery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas Skertich, MD — Rush University Medical Center
- Study coordinator: Research Administrator
- Email: anna_t_alecci@rush.edu
- Phone: 312-942-5500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.