Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Research Administrator
anna_t_alecci@rush.edu
312-942-5500
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2028-03
Participants
Target number of participants: 42
Treatments
Experimental: SG-T: sleeve gastrectomy with tirzepatide
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.
Active_comparator: SG-A: sleeve gastrectomy alone
In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.
Related Therapeutic Areas
Sponsors
Leads: Nicholas Skertich