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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Phentermine 16 mg administered orally once daily in the morning for 52 weeks. The dose is provided as two 8 mg tablets. Participants also receive lifestyle education handouts at each study visit. The intervention is designed to evaluate the efficacy and safety of phentermine for weight loss in adolescents with obesity.
Placebo tablets that are visually identical to phentermine tablets but contain no active pharmaceutical ingredient. Administered orally once daily in the morning for 52 weeks. Participants also receive lifestyle education handouts at each study visit. This control arm is used to evaluate the efficacy and safety of phentermine in adolescents with obesity.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
RECRUITINGDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Percent Change in BMI from Baseline at Week 52
Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.
Time frame: 52 weeks
Number of Treatment-Emergent Adverse Events (TEAEs)
Count of TEAEs deemed probably or definitely related to study drug, including common side effects
Time frame: 52 weeks
Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs)
Count of TEAESIs deemed probably or definitely related to study drug, including tachycardia, hypertension, depression, suicidality, and withdrawal symptoms
Time frame: 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
RECRUITINGThe University of Oklahoma Health Sciences Children's Hospital
Oklahoma City, Oklahoma, United States
RECRUITINGPrisma Health-Midlands Children's Hospital
Columbia, South Carolina, United States
RECRUITING