Phentermine's Impact on Treatment in Teens
Eligible age
12–17 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Russell McCulloh, MD
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Contraindications to phentermine in adults such as:
- ✕ A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);
- ✕ History of glaucoma;
- ✕ Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;
- ✕ Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);
- ✕ Current pregnancy or breastfeeding;
- ✕ Plans to become pregnant within the study duration;
- ✕ Known hypersensitivity to sympathomimetic amines;
Where it's recruiting
Albuquerque
Columbia
Source: ClinicalTrials.gov · NCT07282340 · last updated 2026-06-16