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

What Was Tested

This registered phase 2 trial tested Tirzepatide.

It had 1 arm (groups): Phase II: Treatment with Tirzepatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Primary Objectives: To evaluate the feasibility of administering Tirz in overweight or obese AYA sarcoma patients during the first year after anthracycline therapy.

If any criterion is not met, contributing factors (e.g., ineligibility, refusal, operational barriers) will be documented to guide future trial design.

To evaluate the safety and tolerability of Tirz in AYA sarcoma patients.

Safety will be characterized by the incidence, type, and severity of treatment-related adverse events, graded according to CTCAE v6.0.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 39 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-39 years at enrollment. Overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²) at the time of enrollment. 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. Ability to provide informed consent and willingness to comply with all study procedures, assessments, and follow-up requirements.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: prior or current use of glp-1 receptor agonists; history of pancreatitis, medullary thyroid carcinoma, or men2; current participation in another interventional trial.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Tirzepatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-12-31 with completion listed for 2034-12-31.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.