2024 Tirzepatide-Bariatric Surgery (NCT06721507) | Clinical Trial Compass
RecruitingPhase 4
2024 Tirzepatide-Bariatric Surgery
United States50 participantsStarted 2025-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in inflammatory markers c reactive protein (CRP)
Timeframe: Baseline and 3 months post-drug
2
Change in inflammatory markers interleukin 6 (IL-6)
Timeframe: Baseline and 3 months post-drug
3
Change in inflammatory markers tumor necrosis factor (TNF)
Timeframe: Baseline and 3 months post-drug
4
change in inflammatory markers (leptin)
Timeframe: Baseline and 3 months post-drug
5
change in inflammatory markers (adiponectin)
Timeframe: Baseline and 3 months post-drug
6
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)