RecruitingPhase 2NCT06299891

Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity

Phentermine/Topiramate in Children, Adolescents, and Young Adults With Hypothalamic Obesity: a Pilot and Feasibility Study

Sponsor

Seattle Children's Hospital

Enrollment

24 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Craniopharyngioma Hypothalamic Obesity Hypothalamic Tumor

Summary

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.

Eligibility

Min Age: 6 YearsMax Age: 28 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination weight-loss medication (phentermine/topiramate) is safe and effective for children and young adults who gained significant weight due to a brain tumor or its treatment — a condition called hypothalamic obesity. This type of obesity is caused by damage to the part of the brain that controls hunger and metabolism. **You may be eligible if...** - You are between 6 and 28 years old - You experienced rapid weight gain after a brain tumor diagnosis or treatment - You have obesity (BMI above the 95th percentile for your age, or BMI over 30 if you are 18 or older) - Brain MRI shows injury to the hypothalamus - At least 6 months have passed since your last major tumor treatment - Your hormone replacement and other medications have been stable for at least 2 months **You may NOT be eligible if...** - You have uncontrolled glaucoma or kidney stones - You are pregnant or planning to become pregnant - You have had a recent heart attack or stroke - You have certain psychiatric conditions that would make this medication unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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