ObesityNCT06485089
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
An observational study of Obesity and Breast Cancer Risk, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Breast Cancer Risk
- What is being tested?
- tirzepatide
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Sep 2024to 25 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- • 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
Who cannot join
- • 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kansas Medical Center Breast Cancer Prevention Center
Westwood, Kansas, 66208
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Breast Cancer Risk
- Being tested
- tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tirzepatideDrug
Women taking tirzepatide as part of standard care in the Weight Managment Clinic
| Study group | Role | What they receive |
|---|---|---|
| women using tirzepatide for weight loss | Women attending the University of Kansas Medical Center (KUMC) Weight Management Clinic Receives: Drug: tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Completion rate of 70% or more
Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
Measured: 6 months
Secondary outcomes (5)
Change in mammographic fibroglandular volume
as measured by Volpara software baseline and 6 months
Measured: 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
Measured: 3-6 months
Change in benign breast tissue estrogen response and ELF5 gene expression
Difference in baseline and off study mRNA
Measured: 3-6 months
Assessment of GIP-R expression in breast tissue
GIP- R mRNA and protein
Measured: 3-6 months
Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho
change in blood levels with assays primarily by ELISA
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Sep 2024
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J Fabian, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485089
- Sponsor's protocol ID
- STUDY00160627
- Status last verified
- Oct 2025
- First submitted
- 20 Jun 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Limited number of participants increases risk of identification of individuals
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers in Women With Obesity and Other Risk Factors for Breast Cancer
- ClinicalTrials.gov ID
- NCT06485089
- Acronym / sponsor ID
- STUDY00160627
- Conditions
- Obesity, Breast Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women using tirzepatide for weight loss | – | Drug: tirzepatideWomen attending the University of Kansas Medical Center (KUMC) Weight Management Clinic |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- • BMI 30-45 kg/m2
- 2- fold or higher estimated 10 year or lifetime risk compared to population by standard risk model (BCRAT, BCSC, IBIS
Key exclusion criteria (6 listed)
- • 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tirzepatideWomen taking tirzepatide as part of standard care in the Weight Managment Clinic | Drug | women using tirzepatide for weight loss |
Primary outcome
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months
Time frame: 12 months
Accrual defined as signed consent and ompleting baseline proceedures
Completion rate of 70% or more
Time frame: 6 months
Completion of procedures for biomarker assessment after 3-6 months of tirzeptide
5 secondary outcomes
Change in mammographic fibroglandular volume
Time frame: 6 months
Change in benign breast tissue proliferation
Time frame: 3-6 months
Change in benign breast tissue estrogen response and ELF5 gene expression
Time frame: 3-6 months
Assessment of GIP-R expression in breast tissue
Time frame: 3-6 months
Change in selected adipokines, cytokines, hormones, IGF-1, alpha klotho
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. Limited number of participants increases risk of identification of individuals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol J Fabian, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Breast Cancer Risk, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of design as assessed by accrual rate of 1 or more per month over 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.