A study testing whether a GLP-1 and GIP medicine, tirzepatide, may help during breast cancer treatment.

Recruiting now. Registry record last updated February 12, 2026.

Who can join
Adults 18+, have breast cancer, BMI 27+.
What you take
Tirzepatide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
How long it lasts
The full study runs about 6 years.
What you get
Costs vary by study. Ask the study team what this one covers, including the study medicine, visits and travel, before you sign the consent form.
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Phase Phase 2Sponsor Baylor Research InstituteDrug tirzepatideClass GLP-1/GIPSites 1 USEnrollment target 48

What this study is for

Primary condition: Breast Cancer. Also studied in: Breast Neoplasms, Breast Cancers.

Full scientific study title: Tirzepatide Weight Loss for MRD+ Early Breast Cancer.

Who can join

Age18 and upSexAnyBMI27 or higher

Adults 18+, have breast cancer, BMI 27+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

Key inclusion criteria

  • Female or male patients ≥18 years of age
  • Have a diagnosis of node-positive, hormone receptor-positive (ER+ \> 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  • If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing
  • Patients with multifocal/multicentric cancers are eligible and the largest focus of cancer should be submitted for NGS evaluation. If tested, all tumor foci must meet have ER \> 10%
  • For patients who received neoadjuvant therapy and have discordant hormone receptor and/or HER2 results between the diagnostic biopsy (pre-treatment) and the surgical pathology (post-neoadjuvant treatment), the hormone receptor status and HER2 status of the post-treatment specimen will determine eligibility

Key exclusion criteria

  • Prior bariatric surgery and/or endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer
  • Treatment with a GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, GIP/GLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months
  • History of severe hypersensitivity reaction to GLP-1/Glucagon receptor agonist, GIP/GLP-1/Glucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies
  • Insulin-dependent diabetes
  • Has clinical evidence of diabetic retinopathy

Where this trial is enrolling

This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.

Texas1 site
  • Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
    Dallas, Texas
    Page E Blas, MA214-820-5424page.blas@bswhealth.org

Timeline

Started enrolling: November 26, 2024. Expected completion: December 31, 2030. Last updated on ClinicalTrials.gov: February 12, 2026.

Official source

Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked September 4, 2026. Confirm the current status there before you contact a site:

View on ClinicalTrials.gov →

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