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Purpose

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. 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 - BMI greater than or equal to 45 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 - have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy - enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Exclusion Criteria

  • 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 - patients with active, untreated or symptomatic cholelithiasis or jaundice - current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days - a history of prior metabolic and bariatric surgery - 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Standard of Care plus Drug 		Participant receives drug for 3 months prior to surgery
  • Drug: 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.
    Other names:
    • Mounjaro
    • Zepbound
Active Comparator
Standard of Care Alone
  • Behavioral: Standard of Care
    Participants will be educated on dietary and lifestyle changes

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506

More Details

NCT ID
NCT06721507
Status
Recruiting
Sponsor
Marlene Starr

Study Contact

Marlene Starr, PhD
859-323-0471
marlene.starr@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.