Tirzepatide and Exercise for ALL Survivors with Obesity
This study is for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are also living with obesity. It's testing a combination of two treatments over 28 weeks: Tirzepatide, a once-weekly injection, and a remote, supervised exercise program focused on resistance training. You'll also receive lifestyle counseling every four weeks. The main goal is to see how effective this combined approach is for weight loss. To join, you must be at least 18 years old, have been diagnosed with ALL at least five years ago, and finished your ALL treatment at least two years ago. The study is currently unclear on its recruitment status, but plans to enroll 20 participants.
- Study design
- This is a 28-week, single-arm, open-label Phase II clinical trial, meaning all 20 participants will receive the same combination of treatments.
- What's involved
- You would receive once-weekly Tirzepatide injections, participate in three remote resistance exercise sessions per week, and have lifestyle counseling every four weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome for weight loss is measured at 28 weeks, which is the duration of the intervention.
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NCT07228741
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
Recruiting
PHASE2Ages 18+InterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~20 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:TirzepatideResistance ExerciseLifestyle Counseling
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise.
Measured over 28 weeks (assessed baseline and Week 28)
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Stephanie B Dixon, MD, MPH · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
≥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)
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
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
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
What this trial measures
- To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise.28 weeks (assessed baseline and Week 28)
The effectiveness will be estimated as the proportion of evaluable participants (those completing both week 0 and 28 visits) who achieve at least 5% weight loss from baseline to week 28.