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Obesity (Disorder)Phase 4NCT07257484

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

A Phase 4 study testing Tirzepatide in people with Obesity (Disorder) and Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Obesity (Disorder), Breast Cancer
What is being tested?
Tirzepatide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
8 Jun 2026to 25 Feb 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biologically female
  • Age ≥ 18
  • Obesity as defined by current BMI ≥ 30 kg/m² or ≥ 27.5 kg/m² for individuals of Asian ancestry
  • Postmenopausal as defined by one or more of the following
  • Age ≥60 years
  • Age <60 years with amenorrhea for ≥ 1 year
Show all 12Show fewer
  • Documented bilateral surgical oophorectomy
  • Chemical menopause with the addition of LHRH agonists at least 12 weeks prior to enrolment, and plan to remain on LHRH agonists throughout the trial
  • HR+ (ER and/or PR) stage 0-III breast cancer
  • Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
  • Insurance approval for tirzepatide or willing to pay out of pocket
  • Willing to provide informed consent and comply with study procedures

Who cannot join

  • Stage IV breast cancer
  • Concomitant use of CDK inhibitors
  • Concomitant use of antiHER2 therapy
  • The PI may be consulted regarding enrollment of females receiving other endocrine therapy medications
  • Other active malignancy requiring treatment
  • Enrollment in another investigational clinical trial
Show all 10Show fewer
  • Contraindication to tirzepatide
  • Treatment with a GLP-1 receptor agonist within the last 3 months
  • Diabetes requiring insulin
  • Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lynelle Weis contact

646-962-2423

ljw4002@med.cornell.edu

Henry Cheng contact

646-962-6026

hec4011@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Sarah Schmitz, MD, 646-962-2111, hls9007@med.cornell.edu

    Recruiting

Other trials in United States

About this study

This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.

Being tested
Tirzepatide
Keywords
tirzepatide, hormone receptor positive, HR+, postmenopausal
Medical subject headings
Obesity, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.

Study groups in NCT07257484
Study groupRoleWhat they receive
DrugExperimentalNot described
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants completing week 24 visit with all required assessments

    Measured: 24 weeks

Secondary outcomes (19)

  1. Percent change in body weight from baseline to week 24

    Measured: Baseline, 24 weeks

  2. Absolute change in visceral fat mass from baseline to week 24

    As assessed by SECA scan

    Measured: Baseline, 24 weeks

  3. Percent change in visceral fat mass from baseline to week 24

    As assessed by SECA scan

    Measured: Baseline, 24 weeks

  4. Absolute change in fasting glucose from baseline to week 24

    Measured: Baseline, 24 weeks

  5. Percent change in fasting glucose from baseline to week 24

    Measured: Baseline, 24 weeks

  6. Absolute change in fasting insulin from baseline to week 24

    Measured: Baseline, 24 weeks

  7. Percent change in fasting insulin from baseline to week 24

    Measured: Baseline, 24 weeks

  8. Absolute change in hemoglobin A1c from baseline to week 24

    Measured: Baseline, 24 weeks

  9. Percent change in hemoglobin A1c from baseline to week 24

    Measured: Baseline, 24 weeks

  10. Absolute change in IGF-1 from baseline to week 24

    Measured: Baseline, 24 weeks

  11. Percent change in IGF-1 from baseline to week 24

    Measured: Baseline, 24 weeks

  12. Absolute change in leptin from baseline to week 24

    Measured: Baseline, 24 weeks

  13. Percent change in leptin from baseline to week 24

    Measured: Baseline, 24 weeks

  14. Absolute change in adiponectin from baseline to week 24

    Measured: Baseline, 24 weeks

  15. Percent change in adiponectin from baseline to week 24

    Measured: Baseline, 24 weeks

  16. Absolute change in hs-CRP from baseline to week 24

    Measured: Baseline, 24 weeks

  17. Percent change in hs-CRP from baseline to week 24

    Measured: Baseline, 24 weeks

  18. Absolute change in ghrelin from baseline to week 24

    Measured: Baseline, 24 weeks

  19. Percent change in ghrelin from baseline to week 24

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start8 Jun 2026
  3. Primary completion3 Dec 2027 (estimated)
  4. Study completion25 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07257484
Sponsor's protocol ID
25-06029016
Other IDs
KL2TR002385
Status last verified
Jul 2026
First submitted
20 Nov 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirzepatide in people with Obesity (Disorder) and Breast Cancer, run by Weill Medical College of Cornell University at 1 site 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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lynelle Weis (646-962-2423, ljw4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants completing week 24 visit with all required assessments (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07257484.

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 22 Jul 2026.

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