NCT06734273

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Nicholas Skertich · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
DRUG	Mounjaro	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.
PROCEDURE	Sleeve Gastrectomy	Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.

Timeline

• Start date: 2025-03-10
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2024-12-16
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study