Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer

Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.

Study Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer Risk
• Intervention / Treatment: Drug: tirzepatide

Detailed Description

Women who are scheduled to take tirzepatide for weight loss will be assessed before and after taking drug for change in risk biomarkers. These include mammography, DXA scan, blood draw, and random periareolar fine needle aspiration (RPFNA) for acquisition of benign breast tissue.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Westwood, Kansas, United States, 66208
      • University of Kansas Medical Center Breast Cancer Prevention Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women attending the KUMC Weight Management Clinic and approved or likely to be approved to start a clinical standard of care regimen of tirzepatide for weight loss.

Description

Inclusion Criteria:

• • BMI 30-45 kg/m2

  • Female
  • Insurance approved or likely approved for tirzepatide clinical use *

  • Additional risk factors for breast cancer other than obesity (any one or more) First or second degree with breast cancer Known high density on mammogram (heterogenous or extremely dense) Prior biopsy showing atypical hyperplasia or LCIS Prior treated DCIS Known carrier breast cancer predisposition gene mutation or known mutation in family member .

    2- fold or higher estimated 10 year or lifetime risk compared to population by standard risk model (BCRAT, BCSC, IBIS

Exclusion Criteria:

• • Subglandular breast implants (women with subpectoral implants are eligible if C cup or greater; breast can easily be pulled off the chest wall; and with approval of PI)

  • Clinical contra-indication to incretin mimetics
  • Insurance/third party has denied coverage and participant does not wish to do self-pay.
  • Child-bearing potential and not on contraceptives
  • Prior invasive breast cancer
  • Currently taking any of the following medications: insulin, tamoxifen, raloxifene, letrozole, arimidex, exemestane, incretin mimetics.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women using tirzepatide for weight loss; Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic	Drug: tirzepatide; Women taking tirzepatide as part of standard care in the Weight Managment Clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months	Accrual defined as signed consent and ompleting baseline proceedures	12 months
Completion rate of 70% or more	Completion of procedures for biomarker assessment after 3-6 months of tirzeptide	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mammographic fibroglandular volume	as measured by Volpara software baseline and 6 months	6 months
Change in benign breast tissue proliferation	Difference in baseline and off study Ki-67 in women with baseline Ki-67 of 1 % or higher	3-6 months
Change in benign breast tissue estrogen response and ELF5 gene expression	Difference in baseline and off study mRNA	3-6 months
Assessment of GIP-R expression in breast tissue	GIP- R mRNA and protein	3-6 months
Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho	change in blood levels with assays primarily by ELISA	3-6 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Carol J Fabian, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2024
• Primary Completion (Actual): March 25, 2026
• Study Completion (Actual): March 25, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: STUDY00160627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Limited number of participants increases risk of identification of individuals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No