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NCT07228741 · ClinicalTrials.gov registry record · Phase 2
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT07228741: Recruiting Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT07228741 is a Phase 2 study that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07228741, a Phase 2 study, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Tirzepatide
- BEHAVIORAL Resistance Exercise
- BEHAVIORAL Lifestyle Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-23 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What NCT07228741 shows while recruiting
NCT07228741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Tirzepatide is the first listed.
NCT07228741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07228741 about?
NCT07228741 is a clinical study titled "Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity". 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 c...
What is the current status of trial NCT07228741?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-04-23. Estimated completion is 2028-11.
What interventions are being tested in trial NCT07228741?
The interventions under investigation include: Tirzepatide (DRUG), Resistance Exercise (BEHAVIORAL), Lifestyle Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT07228741?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07228741's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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