2024 Tirzepatide-Bariatric Surgery

Phase 4

Recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Bariatric Surgery
• Interventions: Drug: tirzepatide; Behavioral: Standard of Care

• Registration Number: NCT06721507
• Lead Sponsor: Marlene Starr

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Study Start: 2025-03-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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
• BMI greater than or equal to 45 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
• have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy
• 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
• current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days
• a history of prior metabolic and bariatric surgery
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care plus Drug	tirzepatide	Participant receives drug for 3 months prior to surgery
Standard of Care Alone	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
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 sequencing	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 Outcome Measures

Name	Time	Method
change in insulin	Baseline, 3 months, post-drug, 1-, 6-, and 12-months post surgery	insulin measured in clinic lab
Change in weight	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	patient weight will be measured
30-day surgical complications	1-, 3-, 6-, and 12-months post surgery	Surgical complications will be assessed as standard of care and data evaluated for this study
change in inflammatory markers c reactive protein (CRP)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers interleukin 6 (IL-6)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers tumor necrosis factor (TNF)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (leptin)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (adiponectin)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)	1-, 3-, 6-, and 12-months post surgery	Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in blood pressure	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	blood pressure per standard method in clinic
Change in Hemoglobin A1c	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	HbA1c will be measured by clinic lab
change in blood glucose	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	blood glucose will me measured in clinic lab
change in cholesterol	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	cholesterol measured in clinic lab
change in high-density lipoprotein (HDL)	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	high-density lipoprotein (HDL) measured in clinic lab
change in low-density lipoprotein (LDL)	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	low-density lipoprotein measured by clinic lab
change in triglycerides	Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery	triglycerides measured in clinic lab

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States