Who is eligible for clinical trial NCT06721507?

Participants must meet the protocol's inclusion criteria for Obesity and Obesity-related Medical Conditions. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06721507 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-11

2024 Tirzepatide-Bariatric Surgery (NCT06721507)

Preoperative Tirzepatide for Bariatric Surgery

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Marlene Starr

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (15 items).

Location: University of Kentucky — Lexington, Kentucky

Age range: 18 Years

🧪 Interventions in This Study

tirzepatide (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Kentucky — Lexington, Kentucky

📞 Contact the Study Coordinator

Phone: (859) 323-0471

Email: marlene.starr@uky.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗