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RECRUITING
NCT06721507
PHASE4

2024 Tirzepatide-Bariatric Surgery

Sponsor: Marlene Starr

View on ClinicalTrials.gov

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. 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.

Official title: Preoperative Tirzepatide for Bariatric Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-27

Completion Date

2026-12-31

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

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.

BEHAVIORAL

Standard of Care

Participants will be educated on dietary and lifestyle changes

Locations (1)

University of Kentucky

Lexington, Kentucky, United States