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Anti-obesity Medication

Phentermine/Topiramate for Hypothalamic Obesity

Phase 2
Recruiting
Led By Christian L Roth, MD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to 28

Summary

This trial aims to study the effects of the medication phentermine/topiramate (Ph/T) on hypothalamic obesity (HO) in individuals aged 12-28 years. HO is a

Who is the study for?
This trial is for young people aged 12-28 with hypothalamic obesity, often due to brain tumors like craniopharyngioma. Participants should have issues with excessive hunger or sleepiness. Key eligibility details are not provided, so it's assumed that standard health requirements and consent apply.
What is being tested?
The trial tests Phentermine/Topiramate capsules (Qsymia), which may reduce appetite and increase alertness in patients with hypothalamic obesity. It's a double-blinded study comparing the drug against a placebo over 28 weeks to see if it helps lower BMI and improve other health aspects.
What are the potential side effects?
While specific side effects for this population aren't listed, Qsymia can generally cause mood changes, trouble sleeping, dizziness, taste alterations, constipation or heart palpitations in some individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-emergent adverse events
Secondary study objectives
% change in BMI
Change in body fat mass
Change in energy intake
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug InterventionExperimental Treatment1 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.
Group II: PlaceboPlacebo Group2 Interventions
Matching placebo using capsules matching the appearance of the active drug.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,810 Total Patients Enrolled
Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,556 Total Patients Enrolled
Christian L Roth, MDPrincipal InvestigatorUniversity of Washington, Dept. of Pediatrics
1 Previous Clinical Trials
16 Total Patients Enrolled
Shana E McCormack, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
4 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Craniopharyngioma
18 Patients Enrolled for Craniopharyngioma
~16 spots leftby May 2026