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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Drug: Mounjaro; Procedure: Sleeve Gastrectomy

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Research Administrator; Phone Number: 312-942-5500; Email: anna_t_alecci@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Sr. Clinical Research Coordinator; Phone Number: 312-942-5500; Email: matthew_johnson@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: SG-A: sleeve gastrectomy alone; In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.	Procedure: Sleeve Gastrectomy; Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight Loss	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss		18 months after surgery
Type 2 Diabetes	Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.	12 months after surgery
Type 2 Diabetes	Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.	18 months after surgery
High Blood Pressure		12 months after surgery
High Blood Pressure		18 months after surgery
High Cholesterol	Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement.	12 months after surgery
High Cholesterol	Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement.	18 months after surgery
Sleep Apnea	Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N).	12 months after surgery
Sleep Apnea	Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N)	18 months after surgery
Complications/Side Effects		12 months after surgery
Complications/Side Effects		18 months after surgery

Collaborators and Investigators

• Sponsor: Nicholas Skertich
• Investigators: Principal Investigator: Nicholas Skertich, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 24101008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie the results will be made available following publication for a period of 3 years, dependent on IRB approval to share the data and execution of a data use agreement. Access will be granted to researchers who submit a methodologically sound proposal approved by their IRB. Requests for data access can be made to the Principal Investigator.
• IPD Sharing Time Frame: Start: after publication. End: 3 years after publication.
• IPD Sharing Access Criteria: De-identified individual participant data (IPD) that underlie the results will be made available following publication for a period of 3 years, dependent on IRB approval to share the data and execution of a data use agreement. Access will be granted to researchers who submit a methodologically sound proposal approved by their IRB. Requests for data access can be made to the Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No