Tirzepatide + Resistance Exercise for Obesity in ALL Survivors

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

Must be taking: Tirzepatide

Must not be taking: Weight management drugs

Disqualifiers: Diabetes, Severe renal dysfunction, Recent major cardiovascular event, Severe mental health disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Tirzepatide, a medication for obesity, with personalized, remote resistance exercise can help adult survivors of childhood acute lymphoblastic leukemia (ALL) lose weight. The goal is for participants to lose at least 5% of their body weight over 28 weeks while maintaining muscle mass. The trial is open to those who are overweight or have obesity and have another weight-related health issue, such as high blood pressure or sleep apnea. Participants must be survivors of ALL, have completed treatment at least two years ago, and be willing to participate in both the medication and exercise components of the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use weight management medications or glucose-lowering medications like metformin. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tirzepatide is generally safe for people with obesity. In one study, participants reported common side effects like nausea, diarrhea, and vomiting, but these were usually mild and improved over time. Most participants continued the treatment despite these side effects.

Resistance exercise is also safe for most people. Studies have demonstrated that it can enhance fitness and muscle strength without serious risks. It is particularly beneficial for childhood cancer survivors, who often face challenges with obesity and fitness.

This trial is in Phase 2, indicating that Tirzepatide has already undergone safety testing. The current focus is to learn more about its effectiveness and safety when combined with exercise for weight loss in a specific group. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Tirzepatide for obesity in adult survivors of childhood acute lymphoblastic leukemia because it offers a unique approach compared to standard options like lifestyle changes or bariatric surgery. Tirzepatide is a dual GIP and GLP-1 receptor agonist, meaning it targets two hormones that influence insulin production and appetite, potentially leading to greater weight loss. Additionally, it is administered through weekly subcutaneous injections, which can be more convenient than daily medications, and it aims to preserve lean muscle mass while achieving weight loss. This dual-action mechanism and the convenience of its administration make Tirzepatide a promising option for those struggling with weight management post-cancer treatment.

What evidence suggests that the combination of Tirzepatide and resistance exercise is effective for weight loss in adult survivors of childhood ALL with obesity?

Research has shown that Tirzepatide can help people with obesity lose a significant amount of weight. In one study, participants lost an average of 15.7% of their body weight, while another study showed an average weight loss of 10%. Tirzepatide imitates certain hormones that control hunger and insulin, helping individuals feel full and manage blood sugar levels. In this trial, participants will receive Tirzepatide combined with personalized resistance exercises to further enhance weight loss. This combination could be particularly beneficial for adult survivors of childhood leukemia who struggle with obesity. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephanie B Dixon, MD, MPH

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

Adult survivors of childhood acute lymphoblastic leukemia (ALL) who are now living with obesity or overweight and have at least one weight-related health issue like high blood pressure, high cholesterol, sleep apnea, or heart disease. Participants should be committed to a 28-week program involving medication and exercise.

Inclusion Criteria

I finished my cancer treatment over 2 years ago.

Participant has a negative (urine or blood) pregnancy test (if female)

I am 18 years old or older.

Exclusion Criteria

Participant has a patient health questionnaire-8 (PHQ-8) score of 15 or more at screening

Participant is Non-English speaking

Participant has no access to a smartphone with Bluetooth for accelerometer and WiFi availability for exercise sessions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly Tirzepatide injections and engage in remote, supervised, tailored resistance exercise training three times per week

28 weeks

Weekly visits for Tirzepatide administration and exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistance Exercise
• Tirzepatide

Trial Overview The trial is testing the effectiveness of Tirzepatide combined with remote supervised resistance training for weight loss in these individuals. The goal is for participants to lose at least 5% of their body weight over the course of the study.

How Is the Trial Designed?

Group I: Adult survivors of childhood acute lymphoblastic leukemia (ALL) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07228741?lastUpdPost=2020-01-16_

Resistance Exercise and Incretin Mimetic for ... ... survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. Primary Objective(s):. • To ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964993/

Real‐world use and effectiveness of tirzepatide among ... A recent real‐world study of 343 people with obesity or overweight receiving the maximum maintenance dose of semaglutide (2.4 mg) reported a mean 10.0% ...

3. e-enm.org e-enm.org/journal/view.php?doi=10.3803/EnM.2024.2164

Tirzepatide and Cancer Risk in Individuals with and without ... Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med 2023;29:2909 ...

4. patientcareonline.com patientcareonline.com/view/tirzepatide-delivers-weight-loss-of-15-7-in-adults-with-overweight-obesity

Tirzepatide Delivers Weight Loss of 15.7% in Adults with ... Patients with overweight and obesity treated with tirzepatide achieved mean weight loss of 15.7%, superior to that seen in patients ...

5. globalrph.com globalrph.com/2023/10/obesity-treatment-tirzepatide-semaglutide/

Obesity Treatment With Tirzepatide And Semaglutide In the phase 3 SURMOUNT-1 study involving individuals with obesity or overweight (without diabetes), tirzepatide treatment led to mean body ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07228741?aggFilters=status%3A

Resistance Exercise and Incretin Mimetic for ... ... survivors of childhood acute lymphoblastic leukemia (ALL) living with obesity or overweight with comorbidity. Primary Objective(s):. • To ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4447859/

Energy balance and fitness in adult survivors of childhood ... However, both our study and data from CCSS indicate that half of ALL survivors not exposed to CRT are overweight or obese, increasing their risk for other ...

8. ashpublications.org ashpublications.org/ashclinicalnews/news/2125/Childhood-ALL-Survivors-Struggle-with-Obesity-and

Childhood ALL Survivors Struggle with Obesity and Long ... Yet, as children with ALL age, they have a higher risk for obesity, poor energy balance, and poor fitness later in life compared with their ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323001060

Obesity in Childhood Cancer Survivors: Call for Early ... The most recent data from 269 standard-risk patients with ALL treated without CRT in COG also detected an increase in overweight/obesity rate from 14% at ...

10. mdpi.com mdpi.com/2411-5142/9/1/4

Effect of a Cross-Training and Resistance Exercise Routine ... ... Obesity is associated with residual leukemia following induction therapy for childhood B-precursor acute lymphoblastic leukemia. Blood 2014 ...