Can a Weight-Loss pill help young cancer survivors?
NCT ID NCT07790913
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether a weight-loss medication called phentermine/topiramate, combined with healthy lifestyle counseling, can safely reduce obesity in adolescents and young adults who have survived leukemia or lymphoma. Participants are randomly assigned to receive either the medication plus counseling or counseling alone for 24 weeks, with follow-up for up to a year. The study focuses on feasibility, tolerability, and metabolic health improvements.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Phentermine/topiramate extended-release (a weight-loss medication) combined with lifestyle counseling
- What this could lead to
- If it works, this could offer a safe way to manage obesity and improve metabolic health in young cancer survivors, reducing long-term health risks.
- What could go wrong
- The trial is small and early, so the drug may not prove effective or safe in this specific group. Side effects from the medication are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 24 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant has acute lymphoblastic leukemia (ALL), Hodgkin lymphoma, or non-Hodgkin lymphoma. * Participant has achieved remission and is completing outpatient, maintenance therapy with no further planned inpatient therapy and no use of experimental or investigational treatment OR participant is up to 27 months off therapy (to allow patients who return for 2 year off therapy visits slightly beyond the time point to remain eligible). * Participant will have completed all cycles of therapy that include corticosteroids at the time of study * Participant is age ≥12 and \<25-yrs at study entry * Participant has obesity (BMI ≥95th percentile for age- and sex- or BMI ≥30 kg/m2, whichever threshold is lower). * Participant must provide written informed consent (if ≥18 years) or assent if 12-\<18 years and, if age \<18 a parent or legal guardian must provide consent and willingness to accompany subject to study visits. * If female, participant must be using or willing to use adequate contraception defined as one of the following: double barrier methods, hormonal contraception plus single barrier method, tubal ligation or abstinence. Exclusion Criteria: * Participant has had recent, ongoing weight loss (≥5 kg in past 3-months). * Participant has diabetes mellitus (type 1 or 2 currently on medication or with Hemoglobin A1c ≥6.5%). Participants with a history of steroid induced diabetes requiring insulin who are no longer meet criteria for diabetes, are off any insulin for the past 3 months and have no further planned steroid exposure are eligible. * Participant has poorly controlled hypertensions: current blood pressure * 140/90 on 3 separate occasions (and for age 12 \> 95th percentile on 3 separate occasions) or recent change in anti-hypertensive medication that has not been stable for 3 months * Heart rate ≥120 bpm on 3 separate occasions * Treatment with any medication in the past 3 months with the intention to lose weight (semaglutide, tirzepatide, liraglutide, phentermine, topiramate, naltrexone hydrochloride (HCl)/bupropion HCl, lorcaserin). * Participant currently uses, or has used in the past 3 months, other stimulants/sympathomimetic amines (for attention deficit/hyperactivity disorder (ADHD )or other indication). * Participant has contraindication to phentermine/topiramate ER by package insert (glaucoma or increased intraocular pressure, untreated hyperthyroidism, recent monoamine oxidase inhibitor (MAOI) inhibitor use). * Participant has a health condition that interferes with metabolism (untreated hypothyroidism, growth hormone deficiency with or without treatment, hypothalamic obesity). * Participant is pregnant, planning to become pregnant or breast feeding. * Participant has significant cardiac disease or ECG abnormality including: corrected QT interval (qTC) prolongation \>460msec, congenital heart disease with significant repair, cardiac arrhythmias requiring medication or pacemaker, heart failure requiring medication or uncontrolled hypertension or tachycardia. * Participant has renal dysfunction (eGFR \<60 mL/min), bicarbonate \<18meq/L (labs may be repeated per investigator discretion), history of nephrolithiasis. * Participant has clinically significant liver disease (AST or ALT \>3-times upper limit of normal, lab may be repeated per investigator discretion). * Participant has epilepsy requiring anticonvulsants for seizure management. * Participant has any history of eating disorder or laxative abuse. * Participant has a history of substance abuse. * Prior bariatric surgery. * Participant has a history of bipolar disorder, psychosis, prior suicide attempt or current moderate severity depression (PHQ-9 of 10 or more), report of suicidal ideation in the past 3 months, or self-injurious behavior in the past 3 months. * Participant has relapsed disease or need for transplant. * Participant is unable to swallow pills. * Participant has a genetic or other congenital condition involving global delays (i.e.Trisomy 21, cerebral palsy) or requires a surrogate for over age 18 years. * Use of any investigational medication for treatment of cancer in a clinical study within the past 30 days (must have completed all investigational treatments and corticosteroids and be receiving only outpatient, non- investigational maintenance chemotherapy). * Non-English speaking participant (or primary guardian/caregiver for those \<18 years).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
Contact Email: •••••@•••••
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