Tirzepatide and Bariatric Surgery Study

This study is looking at whether taking tirzepatide before bariatric surgery (weight loss surgery) can improve your health outcomes. Researchers want to see if tirzepatide can reduce inflammation in your body before surgery. They will measure inflammatory markers like C-reactive protein (CRP), interleukin 6 (IL-6), and tumor necrosis factor (TNF) at the start and three months after taking the drug. This study is for adults aged 18 and older who are scheduled for bariatric surgery and have obesity with related health problems. The goal is to see if this treatment could lead to better weight loss, improved metabolic health, and fewer complications after surgery. About 50 people are expected to join.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
What's involved
Participants will be educated on diet and lifestyle changes. You will self-inject 2.5 mg tirzepatide once weekly and keep a diary. Dose adjustments may occur at follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Inflammatory markers will be measured at baseline and 3 months post-drug.

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NCT06721507

2024 Tirzepatide-Bariatric Surgery

Recruiting
PHASE4Ages 18+InterventionalTreatment
Marlene Starr
~50 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:tirzepatideStandard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in inflammatory markers c reactive protein (CRP)
Measured over Baseline and 3 months post-drug
+6 more outcomes measured
Obesity and Obesity-related Medical Conditions
Bariatric Surgery
1 sites across 1 states
Kentucky1
  • Marlene Starr, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky
  • Varun Jain, MD · STUDY_DIRECTOR · University of Kentucky
  • William B Inabnet, MD · STUDY_DIRECTOR · University of Kentucky
  • Simon J Fisher, MD. PhD · STUDY_DIRECTOR · University of Kentucky
  • Philip A Kern, MD · STUDY_DIRECTOR · University of Kentucky
  • Barbara Nikolajczyk, PhD · STUDY_DIRECTOR · University of Kentucky

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Eligibility criteria

Inclusion

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

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
  • Change in inflammatory markers c reactive protein (CRP)Baseline and 3 months post-drug

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

  • Change in inflammatory markers interleukin 6 (IL-6)Baseline and 3 months post-drug

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

  • Change in inflammatory markers tumor necrosis factor (TNF)Baseline and 3 months post-drug

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

  • change in inflammatory markers (leptin)Baseline and 3 months post-drug

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

  • change in inflammatory markers (adiponectin)Baseline and 3 months post-drug

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

  • change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)Baseline and 3 months post-drug

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

  • RNA sequencingat time of surgery

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