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Tests treatment safety and results for Hypothalamic Obesity
Official title Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
ClinicalTrials.gov ID: NCT06299891
What this study is testing
What is Phentermine / Topiramate Extended Release Oral Capsule [Qsymia]?
Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hypothalamic obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 28
You may be able to join if
- Males and Females; Ages 6-28 years (inclusive)
- History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score...
- Obesity (BMI \> 95th%ile for age/sex using CDC 2000 reference for under 18; BMI \> 30 kg/m2 for 18+ years)
- Recent evidence of hypothalamic injury by brain MRI with central review; \>6 months status-post definitive therapy (surgery, chemotherapy, or...
- Stable on pituitary replacement\ and/or appetite-modulating medications (including stimulants) for at least 2 months. \ Adjustments of less than 25%...
You likely can't join if
- Contraindication to Phentermine, Topiramate, or Qsymia as assessed using current package inserts. Including: History of glaucoma and known...
- Known history of nephrolithiasis (kidney stones).
- Current clinical diagnosis of anorexia nervosa or bulimia nervosa in the medical record.
- Known history of metabolic acidosis, low bicarbonate on screening laboratory assessment (below lower limit of normal), or clinically significant bone...
- Current or recent (\<14 days) use of monoamine oxidase inhibitor.
- Known hypersensitivity to sympathomimetic amines.
See the full eligibility criteria
- Males and Females; Ages 6-28 years (inclusive)
- History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score \> 0.2 and/or BMI +5% during the first 6 months following tumor...
- Obesity (BMI \> 95th%ile for age/sex using CDC 2000 reference for under 18; BMI \> 30 kg/m2 for 18+ years)
- Recent evidence of hypothalamic injury by brain MRI with central review; \>6 months status-post definitive therapy (surgery, chemotherapy, or radiation); no major operations/surgeries planned during the study period.
- Stable on pituitary replacement\ and/or appetite-modulating medications (including stimulants) for at least 2 months. \ Adjustments of less than 25% (\<25%) are permitted to hydrocortisone, growth hormone or thyroid...
- Post-menarchal females must use a highly effective form of contraception, unless hypogonadotropic hypogonadism is documented. All participating females of child-bearing potential will have pregnancy testing as outlined...
- Participants must be able to communicate well with the investigative team, must comply with requirements of the study, and be able to provide written informed consent and/or assent for individuals less than 18y with...
- Contraindication to Phentermine, Topiramate, or Qsymia as assessed using current package inserts. Including: History of glaucoma and known hyperthyroidism.
- Known history of nephrolithiasis (kidney stones).
- Current clinical diagnosis of anorexia nervosa or bulimia nervosa in the medical record.
- Known history of metabolic acidosis, low bicarbonate on screening laboratory assessment (below lower limit of normal), or clinically significant bone disease requiring medication (beyond calcium and/or vitamin D).
- Current or recent (\<14 days) use of monoamine oxidase inhibitor.
- Known hypersensitivity to sympathomimetic amines.
- 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...
- Females who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- "Brittle" diabetes insipidus (in the opinion of the referring endocrinologist, e.g. requiring frequent hospitalizations and/or frequent abnormal sodium values).
- Diabetes mellitus requiring insulin/secretagogue. HbA1c \> 8.5% at Screening.
- Clinically significant hyperthyroidism as assessed using thyroid hormone measurements. Clinical measurements within 12 months of baseline/screening may be used to assess this criterion.
- History of clinically significant hypokalemia (low potassium) or current clinically significant hypokalemia (low potassium) on baseline/screening labs.
- 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
- History of seizure in the 12 months prior to Screening.
- History of substance abuse, depression of moderate or greater severity, psychiatric disorder and/or suicidality.
- History of abdominal surgery including gastric bypass.
- Current use of supra-physiologic steroids.
- History of allergy or sensitivity to test agents. Including individuals with known aspirin allergy or hypersensitivity and/or known allergy to FD\&C Yellow No. 5 (tartrazine).
- Concurrent use of carbonic anhydrase inhibitors.
- Concurrent use of non-potassium sparing diuretics.
- New weight management medication (or \>5% decrease in weight over prior 2 months on any current, stable regimen), stimulant, and/or investigational medication within 2 months prior to screening, and/or plans to initiate...
- Cognitive impairment that, in the opinion of the investigator, precludes participation in the study.
- Individuals considered, in the Investigator's opinion, not suitable to participate in the study for reasons other than those indicated above.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 28 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.