Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity
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.
• Age ≥ 12 years and \< 18 years at time of consent;
• Tanner Staging ≥ 2 at the time of screening;
• Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg/m2);
• Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.