Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers

NCT06485089 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: STUDY00160627
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity; Breast Cancer Risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in mammographic fibroglandular volume

  6 months

• Change in benign breast tissue proliferation

  3-6 months

• Change in benign breast tissue estrogen response and ELF5 gene expression

  3-6 months

• Assessment of GIP-R expression in breast tissue

  3-6 months

• Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho

  3-6 months

Study Arms (1)

women using tirzepatide for weight loss

Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic

Drug: tirzepatide

Interventions

tirzepatide DRUG

Women taking tirzepatide as part of standard care in the Weight Managment Clinic

women using tirzepatide for weight loss

Eligibility Criteria

• Age: 40 Years - 64 Years
• Gender Eligibility Details: Must be biologically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center Breast Cancer Prevention Center

Westwood, Kansas, 66208, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, benign breast tissue

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

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

Study Officials

• Carol J Fabian, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: September 14, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)