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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 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.

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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.

Conditions Studied

Craniopharyngioma Hypothalamic Obesity Hypothalamic Tumor

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

FieldValue
Enrollment Target 24 participants
Start Date 2025-03-01
Est. Completion 2026-05-31
Phase Phase 2

Sponsor

Seattle Children's Hospital

168 total trials

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What the Registry Record Tells You About NCT06299891

The ClinicalTrials.gov registry entry for NCT06299891 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (89% lower). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.