Phase 2Recruiting
Phentermine's Impact on Treatment in Teens (PhITT)
Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity
- Sponsor
- Russell McCulloh, MD (Research network)
- Enrolment
- 240 planned
- Conditions
- Childhood Obesity
- Interventions
- Phentermine; Placebo
- Ages
- children
- Registry
- NCT07282340
Full record on ClinicalTrials.gov
From the registry
PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \<18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.
Primary outcomes
- Percent Change in BMI from Baseline at Week 52
History
Primary completion expected
Last registry update
Started
Registered