DelfaGLP-1 Atlas

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Completed

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

2

Recruiting sites

—

Enrollment

25

actual

Study population

Obesity / overweight, Oncology

Key I/E criteria

•BMI 30-45•Female

Primary endpoints

•Feasibility of design•Completion rate of 70% or more

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06485089
Org study IDSTUDY00160627

Timeline

Milestones

Study first posted2024-07-03actual
Study start2024-09-14actual
Primary completion2026-03-25actual
Study completion2026-03-25actual
Last update posted2026-05-28actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age40 Years
Maximum age64 Years
SexFemale
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

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.

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
4
Other clinical outcomes
2
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

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

Time frame:3-6 months

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Change in mammographic fibroglandular volume

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in benign breast tissue proliferation

Time frame:3-6 months

change from baseline, improvement

Other (unclassified)

4 endpoints
Primary/protocol endpoint

Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months

Time frame:12 months

threshold achievement, descriptive

Primary/protocol endpoint

Completion rate of 70% or more

Time frame:6 months

threshold achievement, descriptive

Secondary/protocol endpoint/low confidence

Change in benign breast tissue estrogen response and ELF5 gene expression

Time frame:3-6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Assessment of GIP-R expression in breast tissue

Time frame:3-6 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.