Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-03-27
2026-12-31
Brief Summary
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The major objectives are:
1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
2. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care plus Drug
Participant receives drug for 3 months prior to surgery
tirzepatide
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 Care Alone
Standard of Care
Participants will be educated on dietary and lifestyle changes
Interventions
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tirzepatide
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 Care
Participants will be educated on dietary and lifestyle changes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Marlene Starr
OTHER
Responsible Party
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Marlene Starr
Associate Professor
Principal Investigators
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Marlene Starr, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Varun Jain, MD
Role: STUDY_DIRECTOR
University of Kentucky
William B Inabnet, MD
Role: STUDY_DIRECTOR
University of Kentucky
Simon J Fisher, MD. PhD
Role: STUDY_DIRECTOR
University of Kentucky
Philip A Kern, MD
Role: STUDY_DIRECTOR
University of Kentucky
Barbara Nikolajczyk, PhD
Role: STUDY_DIRECTOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Central Contacts
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Other Identifiers
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97933
Identifier Type: -
Identifier Source: org_study_id
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