2024 Tirzepatide-Bariatric Surgery

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.

Conditions

• Obesity and Obesity-related Medical Conditions
• Bariatric Surgery

Interventions

DRUG

tirzepatide

Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits.

BEHAVIORAL

Standard of Care

Participants will be educated on dietary and lifestyle changes

Sponsors & Collaborators

• Marlene Starr

  lead OTHER

Principal Investigators

• Marlene Starr, PhD · University of Kentucky

• Varun Jain, MD · University of Kentucky

• William B Inabnet, MD · University of Kentucky

• Simon J Fisher, MD. PhD · University of Kentucky

• Philip A Kern, MD · University of Kentucky

• Barbara Nikolajczyk, PhD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-27

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations