Using tirzepatide before bariatric surgery to improve outcomes
Preoperative Tirzepatide for Bariatric Surgery
PHASE4 · University of Kentucky · NCT06721507
This study is testing if taking tirzepatide before weight loss surgery can help patients recover better and have fewer complications after the surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06721507 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering tirzepatide prior to bariatric surgery can enhance postoperative outcomes for patients. The study aims to evaluate the effects of tirzepatide on inflammatory markers and its correlation with weight loss, metabolic improvements, and surgical complications. Participants will be assigned to either receive tirzepatide or standard care for three months before their scheduled laparoscopic or robotic sleeve gastrectomy. The results could inform future therapeutic guidelines for obesity treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 45 kg/m2 or higher and obesity-related comorbidities, scheduled for laparoscopic or robotic sleeve gastrectomy.
Not a fit: Patients with contraindications to tirzepatide or certain medical histories, such as type 1 diabetes or pancreatitis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and improved health for patients undergoing bariatric surgery.
How similar studies have performed: While the specific use of tirzepatide in this context may be novel, similar studies have shown promising results in using medications to enhance surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Marlene Starr, PhD — University of Kentucky
- Study coordinator: Marlene Starr, PhD
- Email: marlene.starr@uky.edu
- Phone: 859-323-0471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity and Obesity-related Medical Conditions, Bariatric Surgery