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

Early Phase 1

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions
• Interventions: Drug: Mounjaro; Procedure: Sleeve Gastrectomy

• Registration Number: NCT06734273
• Lead Sponsor: Nicholas Skertich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-16
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SG-T: sleeve gastrectomy with tirzepatide	Mounjaro	In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery 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.
SG-T: sleeve gastrectomy with tirzepatide	Sleeve Gastrectomy	In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery 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.
SG-A: sleeve gastrectomy alone	Sleeve Gastrectomy	In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Weight Loss	18 months after surgery
Type 2 Diabetes	18 months after surgery	Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
High Blood Pressure	18 months after surgery
High Cholesterol	18 months after surgery	Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement.
Sleep Apnea	18 months after surgery	Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N)
Complications/Side Effects	18 months after surgery

Trial Locations

Locations (1)

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