Recruiting

Tirzepatide

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07257484

Conditions

Obesity (Disorder)

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief 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.

Conditions

Obesity (Disorder)

Breast Cancer

Study ID

NCT07257484

Start date

Jun 8, 2026

Status verified date

Jul, 2026

Completion date

Feb 25, 2028

Anticipated

Primary completion date

Dec 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug

Interventions

Tirzepatide

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

Primary outcome measure

  • Percentage of participants completing week 24 visit with all required assessments [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Lynelle Weis

646-962-2423ljw4002@med.cornell.edu

Henry Cheng

646-962-6026hec4011@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Sarah Schmitz, MD

646-962-2111hls9007@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • tirzepatide
  • hormone receptor positive
  • HR+
  • postmenopausal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-07-22.