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NCT06299891 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
A Phase 2 study of Craniopharyngioma and Hypothalamic Obesity, sponsored by Seattle Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT06299891: Recruiting Phase 2 study of Craniopharyngioma and Hypothalamic Obesity, sponsored by Seattle Children's Hospital.
NCT06299891 is a Phase 2 study of Craniopharyngioma and Hypothalamic Obesity that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 24 participants, below the 212-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06299891, a Phase 2 study of Craniopharyngioma and Hypothalamic Obesity, is actively recruiting participants, sponsored by Seattle Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Incidence of treatment-emergent adverse events including any during withdrawal in study drug vs. placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Phentermine / Topiramate Extended Release Oral Capsule [Qsymia]
Study Locations (2)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Washington
- Seattle Children's - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
What NCT06299891 shows while recruiting
NCT06299891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 212-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Craniopharyngioma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06299891 reports a single indexed study location in Pennsylvania, Washington.
Frequently Asked Questions
What is clinical trial NCT06299891 about?
NCT06299891 is a clinical study titled "Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity". 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...
What is the current status of trial NCT06299891?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2025-03-01. Estimated completion is 2026-05-31.
What conditions does trial NCT06299891 study?
This clinical trial studies the following conditions: Craniopharyngioma, Hypothalamic Obesity, Hypothalamic Tumor.
What interventions are being tested in trial NCT06299891?
The interventions under investigation include: Placebo (OTHER), Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] (DRUG).
Who is sponsoring clinical trial NCT06299891?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06299891 being conducted?
This trial has 2 study locations across Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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