Obesity and Obesity-related Medical ConditionsEarly Phase 1NCT06734273
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
A Early Phase 1 study testing Mounjaro and Sleeve Gastrectomy in people with Obesity and Obesity-related Medical Conditions, run by Nicholas Skertich at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Mounjaro and Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
- Being tested
- Mounjaro, Sleeve Gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MounjaroDrug
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 GastrectomyProcedure or surgery
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 12 months after surgery
Secondary outcomes (11)
Weight Loss
Measured: 18 months after surgery
Type 2 Diabetes
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
Measured: 12 months after surgery
Type 2 Diabetes
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
Measured: 18 months after surgery
High Blood Pressure
Measured: 12 months after surgery
High Blood Pressure
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 18 months after surgery
Complications/Side Effects
Measured: 12 months after surgery
Complications/Side Effects
Measured: 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Mar 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicholas Skertich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Skertich, Rush University Medical Center
- Investigators
- Nicholas Skertich, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734273
- Sponsor's protocol ID
- 24101008
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
- ClinicalTrials.gov ID
- NCT06734273
- Acronym / sponsor ID
- 24101008
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nicholas SkertichUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SG-T: sleeve gastrectomy with tirzepatide | Experimental | Drug: Mounjaro, Procedure: Sleeve GastrectomyIn 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. |
| SG-A: sleeve gastrectomy alone | Active comparator | Procedure: Sleeve GastrectomyIn this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MounjaroIn 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. | Drug | SG-T: sleeve gastrectomy with tirzepatide |
| Sleeve GastrectomySubjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy. | Procedure or surgery | SG-A: sleeve gastrectomy alone, SG-T: sleeve gastrectomy with tirzepatide |
Primary outcome
Weight Loss
Time frame: 12 months after surgery
11 secondary outcomes
Weight Loss
Time frame: 18 months after surgery
Type 2 Diabetes
Time frame: 12 months after surgery
Type 2 Diabetes
Time frame: 18 months after surgery
High Blood Pressure
Time frame: 12 months after surgery
High Blood Pressure
Time frame: 18 months after surgery
High Cholesterol
Time frame: 12 months after surgery
High Cholesterol
Time frame: 18 months after surgery
Sleep Apnea
Time frame: 12 months after surgery
Sleep Apnea
Time frame: 18 months after surgery
Complications/Side Effects
Time frame: 12 months after surgery
Complications/Side Effects
Time frame: 18 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Skertich, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mounjaro and Sleeve Gastrectomy in people with Obesity and Obesity-related Medical Conditions, run by Nicholas Skertich at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.