Acute Lymphoblastic LeukemiaPhase 2NCT07228741
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
A Phase 2 study testing Tirzepatide, Resistance Exercise and Lifestyle Counseling in people with Acute Lymphoblastic Leukemia and Obesity, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Obesity
- What is being tested?
- Tirzepatide, Resistance Exercise and Lifestyle Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
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- 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)
Who cannot join
- 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)
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Stephanie B Dixon, MD, MPH, 888-226-4343, referralinfo@stjude.org
About this study
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):
Read more
- 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.
Read the detailed description
Survivors of childhood ALL are at increased risk for obesity and cardiometabolic disease. Tirzepatide is FDA-approved for weight management in adults and results in significant weight loss but may cause lean mass loss. Resistance exercise programs are feasible and effective in this population.
This study evaluates the efficacy of combining Tirzepatide with resistance exercise in adult survivors of ALL treated with chemotherapy only and at least 2 years off therapy.
The primary objective is to estimate the proportion of participants achieving ≥5% weight loss over 28 weeks. Secondary objectives include adherence to the intervention and changes in body composition, cardiometabolic health, and aging biomarkers.
- Conditions
- Acute Lymphoblastic Leukemia, Obesity
- Being tested
- Tirzepatide, Resistance Exercise, Lifestyle Counseling
- Keywords
- ALL, ALL Survivors
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
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.
Resistance ExerciseBehavioural
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).
Lifestyle CounselingBehavioural
Provided every 4 weeks, focusing on balanced diet, caloric deficit, and symptom management.
| Study group | Role | What they receive |
|---|---|---|
| Adult survivors of childhood acute lymphoblastic leukemia (ALL) | Experimental | 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. 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. Receives: Drug: Tirzepatide; Behavioral: Resistance Exercise; Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks (assessed baseline and Week 28)
Secondary outcomes (2)
To 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.
Measured: 28 weeks
To estimate the average percentage weight loss from week 0 to 28 for participants completing the combined 28-week intervention.
Weight will be monitored at each visit to determine the total amount of weight loss from week 0 to week 28.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start23 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie B Dixon, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228741
- Sponsor's protocol ID
- RESIST
- Other IDs
- NCI-2026-00106
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
- ClinicalTrials.gov ID
- NCT07228741
- Acronym / sponsor ID
- RESIST
- Conditions
- Acute Lymphoblastic Leukemia, Obesity
- Keywords
- ALL, ALL Survivors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Survivors of childhood ALL are at increased risk for obesity and cardiometabolic disease. Tirzepatide is FDA-approved for weight management in adults and results in significant weight loss but may cause lean mass loss. Resistance exercise programs are feasible and effective in this population.
This study evaluates the efficacy of combining Tirzepatide with resistance exercise in adult survivors of ALL treated with chemotherapy only and at least 2 years off therapy.
The primary objective is to estimate the proportion of participants achieving ≥5% weight loss over 28 weeks. Secondary objectives include adherence to the intervention and changes in body composition, cardiometabolic health, and aging biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult survivors of childhood acute lymphoblastic leukemia (ALL) | Experimental | Drug: Tirzepatide, Behavioral: Resistance Exercise, Behavioral: Lifestyle CounselingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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
Key exclusion criteria (32 listed)
- 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)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideA 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. | Drug | Adult survivors of childhood acute lymphoblastic leukemia (ALL) |
| Resistance ExerciseA 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). | Behavioural | Adult survivors of childhood acute lymphoblastic leukemia (ALL) |
| Lifestyle CounselingProvided every 4 weeks, focusing on balanced diet, caloric deficit, and symptom management. | Behavioural | Adult survivors of childhood acute lymphoblastic leukemia (ALL) |
Primary outcome
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)
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.
2 secondary outcomes
To estimate the proportion of participants who adhere to the 28-week combined intervention.
Time frame: 28 weeks
To estimate the average percentage weight loss from week 0 to 28 for participants completing the combined 28-week intervention.
Time frame: 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie B Dixon, MD, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide, Resistance Exercise and Lifestyle Counseling in people with Acute Lymphoblastic Leukemia and Obesity, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie B Dixon, MD, MPH (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.