Phase 2 Obesity Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 6 to 28 years (male or female)
• People who gained weight rapidly around the time of their brain tumor diagnosis or treatment, as assessed by an experienced hormone specialist (for example, a notable increase in weight-for-age measurements within the first 6 months after treatment)
• People who are classified as obese based on standard age- and sex-adjusted charts (for those under 18) or a BMI over 30 (for those 18 and older)
• People who have recent brain MRI results showing damage to the hypothalamus, are more than 6 months past their main cancer treatment (surgery, chemotherapy, or radiation), and have no major surgeries planned during the study
• People who have been on stable hormone replacement or appetite-related medications for at least 2 months (small dose adjustments of less than 25% for certain hormones are allowed)
• Females who have begun their menstrual periods must be using a reliable form of contraception, unless a specific hormonal condition has been documented by a doctor; pregnancy testing will be conducted as part of the study
• People who are able to communicate clearly with the research team, follow study requirements, and provide written agreement to participate — or, for those under 18, whose parent or legal guardian provides consent on their behalf

Who may not be able to join:

• People who have a medical reason they cannot take the study medications (phentermine, topiramate, or Qsymia), including a history of glaucoma or an overactive thyroid
• People with a known history of kidney stones
• People who currently have a clinical diagnosis of anorexia nervosa or bulimia nervosa recorded in their medical records
• People with a history of metabolic acidosis, low bicarbonate levels on blood tests, or significant bone disease requiring medication beyond calcium or vitamin D supplements
• People currently using, or who have used within the past 14 days, a type of medication called a monoamine oxidase inhibitor (MAOI) (confirm with trial site if unsure whether a current medication falls into this category)
• People with a known allergy or sensitivity to a class of medicines called sympathomimetic amines
• People with significant heart or blood pressure conditions, including high blood pressure above defined thresholds for their age, irregular heart rhythm, heart failure, a prolonged heart electrical interval (QTc above 460 msec), long QT syndrome, or a history of coronary artery disease
• Females who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People with severe or unstable diabetes insipidus (a water-balance condition), in the opinion of their hormone specialist
• People with diabetes requiring insulin or certain diabetes medications, or with an HbA1c blood sugar level above 8.5% at screening
• People with a clinically significant overactive thyroid, based on thyroid hormone test results
• People with a significant history of, or current, low potassium levels on blood tests
• People with significant liver disease or liver function test results more than three times the normal upper limit
• People with significant kidney disease, based on a kidney function measurement below a set threshold
• People who have had a seizure in the 12 months before screening
• People with a history of substance abuse, moderate or severe depression, other psychiatric conditions, or suicidality
• People who have had abdominal surgery, including gastric bypass
• People currently taking high-dose steroids above normal physiological levels
• People with a known allergy or sensitivity to the study medications, aspirin, or a food dye called FD&C Yellow No. 5 (tartrazine)
• People currently using a type of medication called a carbonic anhydrase inhibitor
• People currently using diuretics that are not potassium-sparing
• People who have started a new weight management medication, had more than a 5% weight loss in the past 2 months, used a stimulant or investigational medication within the past 2 months, or who plan to start a new weight management approach during the study
• People whose cognitive ability, in the opinion of the investigator, would prevent safe participation in the study
• People considered unsuitable for the study for other reasons, at the investigator's discretion

Important: Always verify eligibility with the trial site directly before applying.