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Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
NCT06299891 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06299891
The ClinicalTrials.gov registry entry for NCT06299891 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06299891 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06299891?
The interventions under investigation include: Placebo (OTHER), Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06299891?
This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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