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

NCT06734273 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24101008
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  12 months after surgery

Secondary Outcomes (11)

• Weight Loss

  18 months after surgery

• Type 2 Diabetes

  12 months after surgery

• Type 2 Diabetes

  18 months after surgery

• High Blood Pressure

  12 months after surgery

• High Blood Pressure

  18 months after surgery

Study Arms (2)

SG-T: sleeve gastrectomy with tirzepatide

EXPERIMENTAL

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; Procedure: Sleeve Gastrectomy

SG-A: sleeve gastrectomy alone

ACTIVE COMPARATOR

In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.

Procedure: Sleeve Gastrectomy

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.

SG-T: sleeve gastrectomy with tirzepatide

Sleeve Gastrectomy PROCEDURE

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

SG-A: sleeve gastrectomy alone; SG-T: sleeve gastrectomy with tirzepatide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicholas Skertich: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Nicholas Skertich, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Administrator

CONTACT

312-942-5500; anna_t_alecci@rush.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start: after publication. End: 3 years after publication.
• 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.

Locations

US (1)