Obesity and Obesity-related Medical ConditionsPhase 4NCT06721507
2024 Tirzepatide-Bariatric Surgery
A Phase 4 study testing tirzepatide in people with Obesity and Obesity-related Medical Conditions and Bariatric Surgery, run by Marlene Starr at 1 site in United States.
Trial summary
This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Bariatric Surgery
- What is being tested?
- tirzepatide
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass surgery
- BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
- have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
- enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
Who cannot join
- any contraindication to the use of tirzepatide (per package insert)
- Personal or family history of medullary thyroid carcinoma
- Patients with Multiple Endocrine Neoplasm syndrome type 2
- Hypersensitivity to tirzepatide
- History of pancreatitis
- Type 1 Diabetes
Show all 14Show fewer
- patients with active, untreated or symptomatic cholelithiasis or jaundice
- consistent use of a GLP-1 or GLP-1/GIP receptor agonist, over the past 90 days
- diagnosed autoimmune disease
- current use of immunosuppressive agents or use within the past 30 days
- moderate or severe substance use disorder according to DSM-5 criteria
- uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
- female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
- a prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Varun Jain, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: Preoperative Tirzepatide for Bariatric Surgery
This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.
The major objectives are:
Read more
- To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
- To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery.
Participants will:
Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.
Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.
Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.
- Being tested
- tirzepatide, Standard of Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirzepatideDrug
Also called Mounjaro, Zepbound
Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits.
Standard of CareBehavioural
Participants will be educated on dietary and lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care plus Drug | Experimental | Participant receives drug for 3 months prior to surgery Receives: Drug: tirzepatide |
| Standard of Care Alone | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory markers c reactive protein (CRP)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
Change in inflammatory markers interleukin 6 (IL-6)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
Change in inflammatory markers tumor necrosis factor (TNF)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
change in inflammatory markers (leptin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
change in inflammatory markers (adiponectin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Inflammatory markers will be measured by ELISA in blood samples drawn from patient.
Measured: Baseline and 3 months post-drug
RNA sequencing
Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery
Measured: at time of surgery
Secondary outcomes (16)
Change in weight
patient weight will be measured
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
30-day surgical complications
Surgical complications will be assessed as standard of care and data evaluated for this study
Measured: 1-,6-, and 12-months post surgery
change in inflammatory markers c reactive protein (CRP)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in inflammatory markers interleukin 6 (IL-6)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in inflammatory markers tumor necrosis factor (TNF)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in inflammatory markers (leptin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in inflammatory markers (adiponectin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Measured: 1-, 6-, and 12-months post surgery
change in blood pressure
blood pressure per standard method in clinic
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
Change in Hemoglobin A1c
HbA1c will be measured by clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in blood glucose
blood glucose will me measured in clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in cholesterol
cholesterol measured in clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in high-density lipoprotein (HDL)
high-density lipoprotein (HDL) measured in clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in low-density lipoprotein (LDL)
low-density lipoprotein measured by clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in triglycerides
triglycerides measured in clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in insulin
insulin measured in clinic lab
Measured: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start27 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marlene Starr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marlene Starr, University of Kentucky
- Investigators
- Marlene Starr, PhD, Principal investigator, University of KentuckyVarun Jain, MD, Study director, University of KentuckyWilliam B Inabnet, MD, Study director, University of KentuckySimon J Fisher, MD. PhD, Study director, University of KentuckyPhilip A Kern, MD, Study director, University of KentuckyBarbara Nikolajczyk, PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721507
- Sponsor's protocol ID
- 97933
- Status last verified
- May 2026
- First submitted
- 3 Dec 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jain V, McMullen CA, Kimbrough JI, Rockich AK, Davenport DL, Hawk GS, Nikolajczyk BS, Kern PA, Fisher SJ, Steiner JP, Inabnet WB 3rd, Starr ME. Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial. J Surg Res. 2026 Mar;319:58-65. doi: 10.1016/j.jss.2026.01.004. Epub 2026 Feb 4.
PubMed 41643256
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Tirzepatide for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06721507
- Acronym / sponsor ID
- 97933
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marlene StarrUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 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 clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.
The major objectives are:
- To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
- To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery.
Participants will:
Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.
Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.
Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus Drug | Experimental | Drug: tirzepatideParticipant receives drug for 3 months prior to surgery |
| Standard of Care Alone | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass surgery
- BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
- have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
- enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
Key exclusion criteria (14 listed)
- any contraindication to the use of tirzepatide (per package insert)
- Personal or family history of medullary thyroid carcinoma
- Patients with Multiple Endocrine Neoplasm syndrome type 2
- Hypersensitivity to tirzepatide
- History of pancreatitis
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 |
|---|---|---|
| tirzepatideAlso: Mounjaro, ZepboundParticipants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits. | Drug | Standard of Care plus Drug |
| Standard of CareParticipants will be educated on dietary and lifestyle changes | Behavioural | Standard of Care Alone |
Primary outcome
Change in inflammatory markers c reactive protein (CRP)
Time frame: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Change in inflammatory markers interleukin 6 (IL-6)
Time frame: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Change in inflammatory markers tumor necrosis factor (TNF)
Time frame: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (leptin)
Time frame: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (adiponectin)
Time frame: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Time frame: Baseline and 3 months post-drug
Inflammatory markers will be measured by ELISA in blood samples drawn from patient.
RNA sequencing
Time frame: at time of surgery
Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery
16 secondary outcomes
Change in weight
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
30-day surgical complications
Time frame: 1-,6-, and 12-months post surgery
change in inflammatory markers c reactive protein (CRP)
Time frame: 1-, 6-, and 12-months post surgery
change in inflammatory markers interleukin 6 (IL-6)
Time frame: 1-, 6-, and 12-months post surgery
change in inflammatory markers tumor necrosis factor (TNF)
Time frame: 1-, 6-, and 12-months post surgery
change in inflammatory markers (leptin)
Time frame: 1-, 6-, and 12-months post surgery
change in inflammatory markers (adiponectin)
Time frame: 1-, 6-, and 12-months post surgery
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Time frame: 1-, 6-, and 12-months post surgery
change in blood pressure
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
Change in Hemoglobin A1c
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in blood glucose
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in cholesterol
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in high-density lipoprotein (HDL)
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in low-density lipoprotein (LDL)
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in triglycerides
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery
change in insulin
Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post 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 14 May 2026.
- Derived from this study: PubMed 41643256Jain V, McMullen CA, Kimbrough JI, Rockich AK, Davenport DL, Hawk GS, Nikolajczyk BS, Kern PA, Fisher SJ, Steiner JP, Inabnet WB 3rd, Starr ME. Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial. J Surg Res. 2026 Mar;319:58-65. doi: 10.1016/j.jss.2026.01.004. Epub 2026 Feb 4.
- Individual participant dataSharing planned: No
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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.
Varun Jain, MD contact
Marlene Starr, PhD principal investigator
University of Kentucky
Varun Jain, MD study director
University of Kentucky
William B Inabnet, MD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tirzepatide in people with Obesity and Obesity-related Medical Conditions and Bariatric Surgery, run by Marlene Starr 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 4 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: looking for participants now, as of the sponsor's last update on 14 May 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Marlene Starr, PhD (859-323-0471, marlene.starr@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory markers c reactive protein (CRP) (time frame: Baseline and 3 months post-drug). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06721507, which also lists 1 linked publication.
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 14 May 2026.