Recruiting
Phase 2

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07874828

Conditions

Sarcoma,Soft Tissue

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Sarcoma,Soft Tissue

Study ID

NCT07874828

Start date

Oct 14, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2036

Anticipated

Primary completion date

Dec 31, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Phase II: Treatment with Tirzepatide

Tirz will be administered as a once-weekly subcutaneous injection using single-dose vials, and a needle and syringe to draw up and administer the prescribed dose. Participants will self-administer the medication after training by the clinical team or pharmacy, including proper needle and syringe technique.

Interventions

Tirzepatide

Given by injection

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Efstratios Koutroumpakis, MD

(713) 563-5439ekoutroumpakis@mdanderson.org

Locations

UT MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Efstratios Koutroumpakis, MD

713-563-5439ekoutroumpakis@mdanderson.org

Principal Investigator:

Efstratios Koutroumpakis, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Overweight
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.