OncoMatch/Clinical Trials/NCT06299891
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Is NCT06299891 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] for hypothalamic obesity.
Treatment: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] — Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness. Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 6-28-year-old individuals with HO.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Lab requirements
Kidney function
GFR < 60 ml/min/1.73m2 excluded
Liver function
ALT > 3 x Upper Limit of Normal (ULN), AST > 3 x ULN excluded
Cardiac function
Clinically significant cardiovascular conditions, including abnormal blood pressure, arrhythmia, heart failure/cardiomyopathy, prolonged QTc (>460 msec), long QT syndrome, coronary artery disease excluded
Clinically significant liver disease and/or known severe hepatic impairment. ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN; Clinically significant kidney disease. GFR<60 ml/min/1.73m2; Clinically significant cardiovascular conditions, as defined as any of the following: i) abnormal blood pressure, defined as: under 13y, 95th%ile +12 mm Hg or > 140/90, whichever is lower; 13y and older, > 140/90 ; ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and/or cardiomyopathy; iv) prolonged QTc interval (QTc > 460 msec), and/or long QT syndrome phenotype and/or positive genotype for long QT syndrome pathogenic; v) history of cardiac disease including coronary artery disease.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
- Seattle Children's · Seattle, Washington
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