Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
2 other identifiers
interventional
20
1 country
1
Brief Summary
This is a 28-week, single-arm, open-label phase II clinical trial evaluating the combination of Tirzepatide and remote, supervised, tailored resistance exercise training to achieve weight loss in adult survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. Primary Objective(s):
- To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise (three sessions per week) in adult survivors of childhood ALL with obesity or overweight (BMI ≥27 kg/m2) with ≥1 weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease). The effectiveness will be estimated as the proportion of evaluable participants who achieve at least 5% weight loss from baseline to week 28. The study will target a proportion of participants achieving 5% weight loss of 70% and consider fewer than 40% achieving 5% weight loss as unacceptable. Secondary Objective(s):
- Estimate the proportion of participants who adhere to the 28-week combined intervention. Adherence to Tirzepatide will be defined as receiving at least 70% of prescribed doses. Adherence to resistance exercise will be defined as attending at least 50% of prescribed exercise sessions. Adherence to the combined intervention will be considered if participants complete the study and meet both the Tirzepatide and exercise adherence endpoint. The adherence to each component of the intervention will also be reported.
- Estimate the average percentage weight loss from week 0 to 28 for participants completing the combined 28-week intervention. The study will target a mean weight reduction of 10% and consider \<5% unacceptable.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2025
CompletedFirst Posted
Study publicly available on registry
November 14, 2025
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
June 4, 2026
June 1, 2026
1.5 years
November 10, 2025
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effectiveness for weight loss of the combined intervention using once weekly Tirzepatide plus remote, supervised, tailored resistance exercise.
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.
28 weeks (assessed baseline and Week 28)
Secondary Outcomes (2)
To estimate the proportion of participants who adhere to the 28-week combined intervention.
28 weeks
To estimate the average percentage weight loss from week 0 to 28 for participants completing the combined 28-week intervention.
28 weeks
Study Arms (1)
Adult survivors of childhood acute lymphoblastic leukemia (ALL)
EXPERIMENTALThis is a 28-week, single-arm, open-label phase II clinical trial evaluating the combination of Tirzepatide and remote, supervised, tailored resistance exercise training to achieve weight loss in adult survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. The primary goal is to achieve ≥5% weight loss while preserving lean muscle mass. Interventions: * Tirzepatide: Weekly subcutaneous injections starting at 2.5 mg, titrated every 4 weeks up to 15 mg as tolerated. * Resistance Exercise: Remote, supervised, tailored resistance training 3 times per week for 28 weeks. * Lifestyle Counseling: Every 4 weeks focused on balanced diet and caloric deficit.
Interventions
A once-weekly subcutaneous injection starting at 2.5 mg and dose escalation every 4 weeks up to a maximum of 15 mg, following FDA-approved guidelines. Dose escalation may be paused for exceptional responders.
Provided every 4 weeks, focusing on balanced diet, caloric deficit, and symptom management.
A remote, supervised, tailored program delivered via a digital platform, with three sessions per week. Supervision is reduced over time (initially 2x/week, then reduced gradually).
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- 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)
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie B Dixon, MD, MPH
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2025
First Posted
November 14, 2025
Study Start
April 23, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2028
Last Updated
June 4, 2026
Record last verified: 2026-06