Preoperative Tirzepatide Treatment Compared to Standard Care for Patients Undergoing Bariatric Surgery
Led by Marlene Starr · Updated on 2026-05-14
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What this Trial Is About
Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve health outcomes for people with obesity and related medical conditions. This study aims to see if tirzepatide reduces inflammation in tissues and blood before surgery and how these changes relate to weight loss, metabolic improvements, and fewer complications after surgery. The trial is a Phase 4 interventional study comparing patients who take tirzepatide with those who do not before their planned surgery.
Participants who are assigned to the tirzepatide group will self-inject 2.5 mg of tirzepatide once weekly for three months before surgery, following dose escalation instructions if needed. Both groups will receive education on dietary and lifestyle changes. During the three months before surgery, participants will visit the endocrine clinic monthly for drug prescription and side effect monitoring. The study continues through the surgery and post-surgery follow-up periods.
Throughout the study, participants will keep a diary of drug use and side effects, and researchers will measure inflammatory markers such as C-reactive protein, interleukin 6, tumor necrosis factor, leptin, adiponectin, and RAAS at baseline, three months after drug use, and several times after surgery. Weight, blood pressure, blood sugar, cholesterol, and surgical complications will also be tracked up to one year after surgery. Participant involvement includes regular clinic visits, lab tests, and monitoring to assess the impact of tirzepatide on surgical outcomes and inflammation.
CONDITIONS
Brief Title
2024 Tirzepatide-Bariatric Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adults enrolled in a multidisciplinary metabolic and bariatric surgery program scheduled for laparoscopic or robotic sleeve gastrectomy or gastric bypass surgery
Body mass index (BMI) of 40 kg/m2 or higher with one or more obesity-related health conditions
Confirmed abstinence from any nicotine use by serum nicotine and metabolite testing
Enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
You will not qualify if you...
Any contraindication to tirzepatide use according to package instructions
Personal or family history of medullary thyroid carcinoma
Diagnosis of Multiple Endocrine Neoplasm syndrome type 2
Hypersensitivity to tirzepatide
History of pancreatitis
Type 1 diabetes
Active, untreated, or symptomatic gallstones or jaundice
Use of GLP-1 or GLP-1/GIP receptor agonists in the past 90 days
Diagnosed autoimmune disease
Current or recent use (past 30 days) of immunosuppressive drugs
Moderate or severe substance use disorder per DSM-5 criteria
Uncontrolled significant psychiatric disorder evaluated by bariatric psychologist
Female who is pregnant, breastfeeding, or plans pregnancy within 1 year after surgery
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive either tirzepatide injections once weekly for 3 months along with dietary and lifestyle education, or standard care alone with dietary and lifestyle education prior to bariatric surgery.
Weekly visits for up to 3 months
Surgery and Immediate Post-operative Care
Duration - Up to discharge
Participants undergo bariatric surgery, including laparoscopic or robotic sleeve gastrectomy or gastric bypass surgery, followed by immediate post-operative care.
1 visit at time of surgery
Post-operative Follow-up
Duration - 12 months
Participants are followed for monitoring of surgical complications and changes in clinical and inflammatory markers for up to 12 months after surgery.
Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial.
Varun Jain, Colleen A McMullen, Joy I Kimbrough...