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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Seattle Children's Hospital
Study ID
NCT06299891
Phase
PHASE2
Status
Recruiting
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Conditions

  • Craniopharyngioma
  • Hypothalamic Obesity
  • Hypothalamic Tumor

Eligibility Criteria

Sex
ALL
Age
6 Years - 28 Years
Healthy Volunteers
Not accepted

Interventions

  • Phentermine / Topiramate Extended Release Oral Capsule [Qsymia] — DRUG
    To assess safety and maximum tolerated dose as well as efficacy on weight loss of Phentermine/Topiramate in individuals with hypothalamic obesity.
  • Placebo — OTHER
    To assess safety and maximum tolerated dose as well as efficacy on weight loss of placebo treatment in individuals with hypothalamic obesity.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug Intervention
    Active drug dose escalation and adjustment: The drug had been used in adolescents with obesity before. For this trial, the FDA approved dose titration will be followed until the highest tolerable dose is reached.
  • Placebo Comparator: Placebo
    Matching placebo using capsules matching the appearance of the active drug.

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: From baseline to completion of week 28 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Kristin Wade
[email protected]
267-398-5761
Seattle Children'sSeattleWashington98101
Stephanie Purdy
[email protected]
206-987-2540
Christian L Roth, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Children's Hospital of Philadelphia· Philadelphia, PASeattle Children's· Seattle, WA

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