RecruitingPhase 2

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

Lead sponsor

M.D. Anderson Cancer Center

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 25-29.9•EF ≥50%

Primary endpoint

•Safety and Adverse Events (AEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07874828

Org study ID2026-0135

Secondary IDNCI-2026-07665NCI-CTRP Clinical Trials Registry

Timeline

Milestones

Study start2026-10-14actual

Study first posted2026-10-15actual

Last update posted2026-10-20actual

Primary completion2034-12-31estimated

Study completion2036-12-31estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age39 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Safety and Adverse Events (AEs)

Time frame:Through study completion; an average of 1 year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.