Preventing heart problems in overweight/obese young sarcoma survivors with tirzepatide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label feasibility study conducted at MD Anderson focusing on overweight or obese AYA sarcoma survivors who completed doxorubicin-based treatment about three months before enrollment. The study will measure feasibility through enrollment, visit completion, and adherence to tirzepatide over the first year, along with safety data on treatment-related adverse events. Secondary aims include assessing subclinical cardiotoxicity using metrics like LVEF, GLS, and related cardiac parameters. Eligible participants must have preserved cardiac function, adequate performance status, and reproductive controls as required. The trial will inform whether a larger, controlled evaluation of tirzepatide in this population is practical and safe.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-39 years at enrollment
* Histologically confirmed soft tissue or bone sarcoma with treatment that included Dox ≥ 300 mg/m².
* Completed chemotherapy 3 months prior to enrollment; patient must be in remission at the time of enrollment with no planned systemic therapy, radiation therapy, or surgical oncologic intervention anticipated within the next 12 months.
* Overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²) at the time of enrollment.
* LVEF ≥ 50% at the time of enrollment with no symptoms of heart failure (NYHA class I-II).
* ECOG performance status ≤2 (equivalent to Karnofsky ≥60%) at the time of enrollment.
* Reproductive considerations:

  * Women of childbearing potential must agree to use adequate contraception (hormonal, barrier, IUD, or abstinence) beginning at enrollment and continuing for the duration of Tirz therapy.
  * Men must agree to use adequate contraception during study treatment and for 4 months after completion of Tirz.
  * Pregnancy testing will follow MD Anderson Policy CLN1114.
* Ability to provide informed consent and willingness to comply with all study procedures, assessments, and follow-up requirements.

Exclusion Criteria:

* Preexisting diabetes mellitus requiring pharmacologic therapy.
* Prior or current use of GLP-1 receptor agonists.
* Ongoing active malignancy or ongoing systemic therapy for cancer treatment.
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
* History of pancreatitis, medullary thyroid carcinoma, or MEN2.
* Current participation in another interventional trial.
* Pregnancy or breastfeeding.
* Contraindication to GLP-1/GIP receptor agonists.
* Psychiatric illness/social situations that would limit compliance with study requirements.

Where it's running

• UT MD Anderson
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Efstratios Koutroumpakis, MD — UT MD Anderson
• Study coordinator: Efstratios Koutroumpakis, MD
• Email: ekoutroumpakis@mdanderson.org
• Phone: (713) 563-5439

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.