Recruiting

Tirzepatide

Sponsor:

Marlene Starr

Code:

NCT06721507

Conditions

Obesity and Obesity-related Medical Conditions

Bariatric Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

tirzepatide

Standard of Care

Study Details

Brief 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

Study ID

NCT06721507

Start date

Mar 27, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard of Care plus Drug

Participant receives drug for 3 months prior to surgery

active comparator: Standard of Care Alone

Interventions

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.

Standard of Care

Participants will be educated on dietary and lifestyle changes

Primary outcome measure

  • Change in inflammatory markers c reactive protein (CRP) [ Time Frame: Baseline and 3 months post-drug ]
  • Change in inflammatory markers interleukin 6 (IL-6) [ Time Frame: Baseline and 3 months post-drug ]
  • Change in inflammatory markers tumor necrosis factor (TNF) [ Time Frame: Baseline and 3 months post-drug ]
  • change in inflammatory markers (leptin) [ Time Frame: Baseline and 3 months post-drug ]
  • change in inflammatory markers (adiponectin) [ Time Frame: Baseline and 3 months post-drug ]
  • change in inflammatory markers renin-angiotensin-aldosterone system (RAAS) [ Time Frame: Baseline and 3 months post-drug ]
  • RNA sequencing [ Time Frame: at time of surgery ]

Central Contacts and Locations

Central contacts

Marlene Starr, PhD

859-323-0471marlene.starr@uky.edu

Varun Jain, MD

vja233@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

More Information

Sponsor

Marlene Starr

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marlene Starr on 2026-05-14.