NCT06721507 2024 Tirzepatide-Bariatric Surgery
| NCT ID | NCT06721507 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Marlene Starr |
| Condition | Obesity and Obesity-related Medical Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-03-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, 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) 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 * 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
Contact & Investigator
Marlene Starr, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT06721507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity and Obesity-related Medical Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06721507 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06721507 currently recruiting?
Yes, NCT06721507 is actively recruiting participants. Contact the research team at marlene.starr@uky.edu for enrollment information.
Where is the NCT06721507 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06721507 clinical trial?
NCT06721507 is sponsored by Marlene Starr. The principal investigator is Marlene Starr, PhD at University of Kentucky. The trial plans to enroll 50 participants.
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