Tests tirzepatide in young adult sarcoma survivors with excess weight
Tests tirzepatide in young adult sarcoma survivors who are overweight or obese.
Plain-language title generated from the registry record
Registry title: PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 39 years old?
Source: NCT07874828, who can take part
Where in United States
- UT MD AndersonHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT07874828
- Record updated
- 20 October 2026
- Original description
This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic. The study will enroll young adults (18-39 years) with soft tissue or bone sarcoma who are overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²), have completed Dox-based chemotherapy (≥300 mg/m²) approximately three months prior to enrollment, and have preserved LVEF (≥50%) preenrollment.Read full original descriptionShow less
PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study
This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic. The study will enroll young adults (18-39 years) with soft tissue or bone sarcoma who are overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²), have completed Dox-based chemotherapy (≥300 mg/m²) approximately three months prior to enrollment, and have preserved LVEF (≥50%) preenrollment.
Inclusion: 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: Prior or current use of GLP-1 receptor agonists; 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; Preexisting diabetes mellitus requiring pharmacologic therapy; Ongoing active malignancy or ongoing systemic therapy for cancer treatment; History of pancreatitis, medullary thyroid carcinoma, or MEN2; Psychiatric illness/social situations that would limit compliance with study requirements; Current participation in another interventional trial; Pregnancy or breastfeeding; Contraindication to GLP-1/GIP receptor agonists.