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NCT Number: NCT06721507

2024 Tirzepatide-Bariatric Surgery

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.

Recruiting

Interested in participating?

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

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.

Other names: Mounjaro, Zepbound

Standard of Care

Behavioral

Participants will be educated on dietary and lifestyle changes

Primary outcomes

  1. Change in inflammatory markers c reactive protein (CRP)

    Time frame: Baseline and 3 months post-drug

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  2. Change in inflammatory markers interleukin 6 (IL-6)

    Time frame: Baseline and 3 months post-drug

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  3. Change in inflammatory markers tumor necrosis factor (TNF)

    Time frame: Baseline and 3 months post-drug

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  4. change in inflammatory markers (leptin)

    Time frame: Baseline and 3 months post-drug

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  5. change in inflammatory markers (adiponectin)

    Time frame: Baseline and 3 months post-drug

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  6. change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

    Time frame: Baseline and 3 months post-drug

    Inflammatory markers will be measured by ELISA in blood samples drawn from patient.

  7. RNA sequencing

    Time frame: at time of surgery

    Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery

Secondary outcomes

  1. Change in weight

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    patient weight will be measured

  2. 30-day surgical complications

    Time frame: 1-,6-, and 12-months post surgery

    Surgical complications will be assessed as standard of care and data evaluated for this study

  3. change in inflammatory markers c reactive protein (CRP)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  4. change in inflammatory markers interleukin 6 (IL-6)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  5. change in inflammatory markers tumor necrosis factor (TNF)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  6. change in inflammatory markers (leptin)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  7. change in inflammatory markers (adiponectin)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  8. change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

    Time frame: 1-, 6-, and 12-months post surgery

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  9. change in blood pressure

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    blood pressure per standard method in clinic

  10. Change in Hemoglobin A1c

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    HbA1c will be measured by clinic lab

  11. change in blood glucose

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    blood glucose will me measured in clinic lab

  12. change in cholesterol

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    cholesterol measured in clinic lab

  13. change in high-density lipoprotein (HDL)

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    high-density lipoprotein (HDL) measured in clinic lab

  14. change in low-density lipoprotein (LDL)

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    low-density lipoprotein measured by clinic lab

  15. change in triglycerides

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    triglycerides measured in clinic lab

  16. change in insulin

    Time frame: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    insulin measured in clinic lab

Study contacts

Contact information is provided by the study sponsor or research team.

Marlene Starr, PhD

CONTACT

[email protected]

859-323-0471

Varun Jain, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Marlene Starr

Other

Registry information

Official study title

Preoperative Tirzepatide for Bariatric Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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