Actively Recruiting
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
Led by St. Jude Children's Research Hospital · Updated on 2026-04-24
20
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 5 years since diagnosis of acute lymphoblastic leukemia (ALL) treated only with chemotherapy
- At least 2 years since completion of therapy
- Negative pregnancy test if female
- Age 18 years or older at enrollment
- Obesity (BMI > 30 kg/m2) or overweight (BMI > 27 kg/m2) with at least one weight-related health condition such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- Hypertension defined as treated or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg
- Dyslipidemia defined as treated or LDL ≥160 mg/dL, triglycerides ≥150 mg/dL, or low HDL (men <40 mg/dL, women <50 mg/dL)
- Presence of obstructive sleep apnea
- Cardiovascular disease including ischemic cardiovascular disease or NYHA Functional Class I-III heart failure
You will not qualify if you...
- Known diabetes or laboratory evidence of diabetes including HbA1c ≥ 6.5%
- Use of weight management medication in past 3 months or significant weight loss >5 kg in last 3 months
- Severe renal dysfunction (eGFR <30 mL/min/1.73 m2)
- Use of specified weight loss drugs including Saxenda®, Xenical®/Alli®, Meridia®, Acutrim®, Sanorex®, Adipex®, BELVIQ®, Qsymia®, Contrave®, or generic incretin mimetics
- Use of metformin or other glucose-lowering medication
- Multiple Endocrine Neoplasia Type 2 (MEN2) or family history of medullary thyroid cancer
- History of major cardiovascular event in past 3 months or unstable heart failure (NYHA class IV)
- Uncontrolled hypertension during assessment (SBP ≥160 mmHg or DBP ≥100 mmHg)
- Known acute or chronic hepatitis or significant liver disease
- Known chronic pancreatitis or recent acute pancreatitis within past year
- Pregnant, within 3 months postpartum, nursing, or planning pregnancy
- Significant gastric emptying problems or medications affecting GI motility (excluding PPIs and H2 blockers)
- Organ transplant recipient or awaiting transplant
- Active cancer or treatment for active cancer
- Untreated hypothyroidism with TSH >10 uIU/mL or symptomatic
- Severe mental health disorders or history of suicide attempt
- PHQ-8 score of 15 or higher at screening
- History of drug or alcohol use disorder impacting study participation
- Marijuana use in past 3 months and unwillingness to abstain
- Inability or unwillingness to perform self-injections without assistance
- Cognitive impairment affecting participation
- Non-English speaking
- No access to smartphone with Bluetooth and WiFi
- Residence in a state where medication shipping is restricted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Stephanie B Dixon, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here