Recruiting
Early Phase 1

Sleeve Gastrectomy with Tirzepatide

Sponsor:

Nicholas Skertich

Code:

NCT06734273

Conditions

Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Mounjaro

Sleeve Gastrectomy

Study Details

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.

Conditions

Obesity and Obesity-related Medical Conditions

Study ID

NCT06734273

Start date

Mar 10, 2025

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Sleeve Gastrectomy

Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.

Primary outcome measure

  • Weight Loss [ Time Frame: 12 months after surgery ]

Central Contacts and Locations

Central contacts

Research Administrator

312-942-5500anna_t_alecci@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Sr. Clinical Research Coordinator

312-942-5500matthew_johnson@rush.edu

More Information

Sponsor

Nicholas Skertich

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nicholas Skertich on 2026-05-08.