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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Nicholas Skertich
Study ID
NCT06734273
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Weight Loss [ Time Frame: 12 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Sr. Clinical Research Coordinator
[email protected]
312-942-5500

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, IL

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