RecruitingPhase 2

Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity

Lead sponsor

St. Jude Children's Research Hospital

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Oncology

Eligibility highlights

•BMI ≥30

Primary endpoint

•≥5% weight-loss responders

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 IDNCT07228741

Org study IDRESIST

Secondary IDNCI-2026-00106NCI Clinical Trial Registration Program

Timeline

Milestones

Study first posted2025-11-14actual

Study start2026-04-23actual

Last update posted2026-04-24actual

Primary completion2027-11estimated (month precision)

Study completion2028-11estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightOncology

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•≥5 years from diagnosis of acute lymphoblastic leukemia (ALL) treated with chemotherapy only

•≥2 years from completion of therapy

•Participant has a negative (urine or blood) pregnancy test (if female)

Consistent with the FDA-approval for marketing of Tirzepatide for the treatment of obesity:

•Age ≥18 years at the time of enrollment

•Participant has obesity (BMI > 30kg/m2) or overweight (BMI > 27kg/m2) with ≥1 weight related co-morbidity (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)

-hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg or diastolic blood pressure (DBP) ≥80 mmHg

-dyslipidemia: treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L) for men or HDL<50 mg/dL (1.3 mmol/L) for women

-obstructive sleep apnea

-cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)

Exclusion criteria

•Participant has known diabetes or is found at baseline to have laboratory evidence of diabetes including HbA1c ≥ 6.5%

•Participant is using or has used weight management medication in the past 3 months or had recent significant weight loss > 5kg in the last 3 months Severe renal dysfunction (eGFR <30 mL/min/1.73 m²)

-Saxenda® (liraglutide 3.0 mg)

-Xenical®/Alli® (orlistat)

-Meridia® (sibutramine)

-Acutrim® (phenylpropanolamine)

-Sanorex® (mazindol)

-Adipex® (phentermine)

-BELVIQ® (lorcaserin)

-Qsymia® (phentermine/topiramate combination)

-Contrave® (naltrexone/bupropion)

-Compounded or generic incretin mimetic (GLP-1) medication

Note: Use of metformin or any other glucose-lowering medication, whether prescribed for polycystic ovary syndrome or diabetes prevention is not permitted.

•Participant has Multiple Endocrine Neoplasia Type 2 (MEN2) or family history of medullary thyroid cancer

•Participant has severe renal dysfunction (renal-eGFR <30 mL/min/1.73)

•Participant has history of major cardiovascular event in past 3 months (e.g. acute myocardial infarction, cerebrovascular accident, unstable angina, hospitalization due to congestive heart failure or currently NYHA class IV heart failure symptoms)

•Participant has uncontrolled hypertension during clinic assessment (SBP ≥160 mmHg or DBP ≥100 mmHg) ▪ Participant has known acute or chronic hepatitis or signs and symptoms of other liver disease determined by alanine aminotransferase test (ALT) > 3 times the upper normal limit

•Participant has known chronic pancreatitis or recent acute pancreatitis (in the past 1 year)

•Participant is pregnant, or within 3 months post-partum, or nursing, or planning to become pregnant

•Participant has clinically significant gastric emptying abnormality or chronically takes medications that affect GI motility (does not include Proton pump inhibitor (PPI) or histamine 2 blockade)

•Participant has a transplanted organ or awaiting a transplant

•Participant has current active cancer or undergoing treatment for active cancer

•Participant has untreated hypothyroidism with thyroid-stimulating hormone (TSH) > 10 uIU/mL or symptomatic

•Participant has severe mental health disorder (e.g.major depressive disorder, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) or a history of suicide attempt

•Participant has a patient health questionnaire-8 (PHQ-8) score of 15 or more at screening

•Participant has a history of known drug or alcohol use disorder that in the opinion of the investigator may preclude the participant from following and completing the protocol

•Participant has history of self-reported marijuana use in the past 3 months and unwilling to abstain during the trial.

•Participant is unwilling or unable to perform self-injections of study drug (visually impaired or physically limited) and does not have assistance of a sighted individual/support person who is trained

•Participant has cognitive impairment that, in the opinion of the investigator, would preclude the ability to participate in the intervention including self-injections and virtual study visits

•Participant is Non-English speaking

•Participant has no access WiFi availability for exercise sessions

•Participant lives in a state that we cannot ship medication per current St. Jude Pharmacy restrictions

Endpoints (3)

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.

Coverage by outcome category

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise.

Time frame:28 weeks (assessed baseline and Week 28)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

To estimate the average percentage weight loss from week 0 to 28 for participants completing the combined 28-week intervention.

Time frame:28 weeks

Body weight, % change

percent change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint

To estimate the proportion of participants who adhere to the 28-week combined intervention.

Time frame:28 weeks

threshold achievement, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 July 6, 2026 snapshot.