Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06721507

Preoperative Tirzepatide Treatment Compared to Standard Care for Patients Undergoing Bariatric Surgery

Led by Marlene Starr · Updated on 2026-05-14

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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

Eligible

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)
Not Eligible

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
  • Prisoner status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

Visits at 1, 6, and 12 months post surgery

Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

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Research Team

M

Marlene Starr, PhD

V

Varun Jain, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/41643256