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

May 5, 2026 updated by: Nicholas Skertich
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Weight Loss
Time Frame: 12 months after surgery
12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 18 months after surgery
18 months after surgery
Type 2 Diabetes
Time Frame: 12 months after surgery
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
12 months after surgery
Type 2 Diabetes
Time Frame: 18 months after surgery
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
18 months after surgery
High Blood Pressure
Time Frame: 12 months after surgery
12 months after surgery
High Blood Pressure
Time Frame: 18 months after surgery
18 months after surgery
High Cholesterol
Time Frame: 12 months after surgery
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
Time Frame: 18 months after surgery
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
Time Frame: 12 months after surgery
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
Time Frame: 18 months after surgery
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
Time Frame: 12 months after surgery
12 months after surgery
Complications/Side Effects
Time Frame: 18 months after surgery
18 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicholas Skertich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas Skertich, MD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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