Tests tirzepatide with exercise for weight loss in childhood leukemia survivors

Who can take part

• ≥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); 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 take part

• 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 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 lives in a state that we cannot ship medication per current St. Jude Pharmacy restrictions
• Participant has Multiple Endocrine Neoplasia Type 2 (MEN2) or family history of medullary thyroid cancer
• 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 current active cancer or undergoing treatment for active cancer
• 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 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 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 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); 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 severe renal dysfunction (renal-eGFR <30 mL/min/1.73)
• 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 untreated hypothyroidism with thyroid-stimulating hormone (TSH) > 10 uIU/mL or symptomatic
• 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 WiFi availability for exercise sessions