DRUG
Tirzepatide
Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.
Status
Recruiting
Phase
Phase 4
Enrollment
30
Locations
1
Results
Not posted
Publications
0
Study 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. 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.
Interventions
DRUG
Participants will take tirzepatide weekly for 24 weeks. The dose will be adjusted on a monthly basis as clinically indicated.
Timeline
First posted
Dec 2, 2025
Study start
Jun 8, 2026
Primary completion
Dec 3, 2027
Study completion
Feb 25, 2028
Results posted
Not reported
Registry updated
Jul 22, 2026
Outcomes
Percentage of participants completing week 24 visit with all required assessments
Time frame · 24 weeks
Percent change in body weight from baseline to week 24
Time frame · Baseline, 24 weeks
Absolute change in visceral fat mass from baseline to week 24
Time frame · Baseline, 24 weeks
As assessed by SECA scan
Percent change in visceral fat mass from baseline to week 24
Time frame · Baseline, 24 weeks
As assessed by SECA scan
Absolute change in fasting glucose from baseline to week 24
Time frame · Baseline, 24 weeks
Percent change in fasting glucose from baseline to week 24
Time frame · Baseline, 24 weeks
Absolute change in fasting insulin from baseline to week 24
Time frame · Baseline, 24 weeks
Percent change in fasting insulin from baseline to week 24
Time frame · Baseline, 24 weeks
Absolute change in hemoglobin A1c from baseline to week 24
Time frame · Baseline, 24 weeks
Percent change in hemoglobin A1c from baseline to week 24
Time frame · Baseline, 24 weeks
Absolute change in IGF-1 from baseline to week 24
Time frame · Baseline, 24 weeks
Eligibility
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Weill Cornell Medicine
New York, New York, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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