Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07228741
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    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 Exercise — BEHAVIORAL
    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 Counseling — BEHAVIORAL
    Provided every 4 weeks, focusing on balanced diet, caloric deficit, and symptom management.

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adult survivors of childhood acute lymphoblastic leukemia (ALL)
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Stephanie B Dixon, MD, MPH
[email protected]
888-226-4343

Find similar trials in Memphis, TN

By condition
Leukemia (other)Obesity / overweight
By specialty
OncologyBlood cancerEndocrinologyMetabolic healthWeight loss
By research site
St. Jude Children's Research Hospital· Memphis, TN

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