2024 Tirzepatide-Bariatric Surgery

NCT06721507 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 97933
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
2. 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.

Conditions

Obesity and Obesity-related Medical Conditions; Bariatric Surgery

Outcome Measures

Primary Outcomes (7)

• Change in inflammatory markers c reactive protein (CRP)

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

  Baseline and 3 months post-drug

• Change in inflammatory markers interleukin 6 (IL-6)

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

  Baseline and 3 months post-drug

• Change in inflammatory markers tumor necrosis factor (TNF)

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

  Baseline and 3 months post-drug

• change in inflammatory markers (leptin)

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

  Baseline and 3 months post-drug

• change in inflammatory markers (adiponectin)

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

  Baseline and 3 months post-drug

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

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

  Baseline and 3 months post-drug

• RNA sequencing

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

  at time of surgery

Secondary Outcomes (16)

• Change in weight

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

• 30-day surgical complications

  1-, 3-, 6-, and 12-months post surgery

• change in inflammatory markers c reactive protein (CRP)

  1-, 3-, 6-, and 12-months post surgery

• change in inflammatory markers interleukin 6 (IL-6)

  1-, 3-, 6-, and 12-months post surgery

• change in inflammatory markers tumor necrosis factor (TNF)

  1-, 3-, 6-, and 12-months post surgery

Study Arms (2)

Standard of Care plus Drug

EXPERIMENTAL

Participant receives drug for 3 months prior to surgery

Drug: tirzepatide

Standard of Care Alone

ACTIVE COMPARATOR

Behavioral: Standard of Care

Interventions

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.

Also known as: Mounjaro, Zepbound

Standard of Care plus Drug

Standard of Care BEHAVIORAL

Participants will be educated on dietary and lifestyle changes

Standard of Care Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marlene Starr: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide; Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marlene Starr, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Varun Jain, MD

  University of Kentucky

  STUDY DIRECTOR

• William B Inabnet, MD

  University of Kentucky

  STUDY DIRECTOR

• Simon J Fisher, MD. PhD

  University of Kentucky

  STUDY DIRECTOR

• Philip A Kern, MD

  University of Kentucky

  STUDY DIRECTOR

• Barbara Nikolajczyk, PhD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Marlene Starr, PhD

CONTACT

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

Varun Jain, MD

CONTACT

vja233@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)