New combo therapy aims to help leukemia survivors shed pounds
NCT ID NCT07228741
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a weight loss program for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or have obesity. Participants receive a weekly injection of tirzepatide plus remote, supervised resistance exercise three times a week for 28 weeks. The goal is to see if at least 70% of participants lose 5% or more of their body weight. The study involves 20 people and is currently recruiting.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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St. Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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