Clinical trial · Observational
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
NCT06485089CI-TRIAL-00112761completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Risk | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tirzepatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- women using tirzepatide for weight loss
- description
- Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic
- interventionNames
- Drug: tirzepatide
Primary outcomes (2)
- measure
- Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
- timeFrame
- 12 months
- description
- Accrual defined as signed consent and ompleting baseline proceedures
- measure
- Completion rate of 70% or more
- timeFrame
- 6 months
- description
- Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.