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

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated July 28, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria expanded, about 75 words
    • Study description revised
    • Site contacts updated at 2 of 2 sites
    v7
  2. Primary completion date: May 31, 2026 to Feb 28, 2026
    • Site details revised at 1 of 2 sites
    v6
  3. Start date: Aug 1, 2024 to Mar 1, 2025
    • Eligibility criteria shortened, about 13 words
    • Site contacts updated at 2 of 2 sites
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2024 to Aug 1, 2024
    • Site details revised at 2 of 2 sites
    v4
  5. Start date: Mar 15, 2024 to May 1, 2024v3
  6. Start date: Mar 1, 2024 to Mar 15, 2024
    • Interventions: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] (Drug) to Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] (Drug), Placebo (Other)
    • Study description expanded, about 2 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06299891
Lead Sponsor Seattle Children's Hospital
Collaborators: Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Hypothalamic Obesity, Hypothalamic Tumor, Craniopharyngioma
Related terms Craniopharyngioma, Hypothalamic Neoplasms, Sexual Infantilism
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov