RecruitingPhase 2

Phentermine's Impact on Treatment in Teens

Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well phentermine works and how safe it is for teens ages 12 to 17 with obesity. Teens will take either 16 mg of phentermine or a placebo (a pill with no active drug) each day for 52 weeks. A follow-up check will take place during the 2 weeks after treatment stops.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 12 to 17 years old when agreeing to join.
  • Have started puberty, at Tanner stage 2 or higher.
  • Have obesity: a BMI at or above the 95th percentile for age and sex, or a BMI of at least 30. BMI is a measure based on height and weight.
  • Biological females must agree to approved birth control methods or not have sex.

Who can't join

  • Certain heart or blood vessel diseases, an abnormal heart test, a resting heart rate over 100, severe high blood pressure, or use of blood pressure medicine.
  • Glaucoma (an eye disease), an allergy to stimulant-like drugs, pregnancy, breastfeeding, or plans to become pregnant during the study.
  • Past drug dependence, current illegal drug use, or nicotine use now or within the past 3 months.
  • Diabetes, medicine for diabetes or prediabetes, or certain hormone, liver, kidney, or blood fat problems. Some genetic causes of obesity also rule out joining.
  • Certain medicines, including MAO inhibitors within 14 days; weight-loss medicines, prescribed diets, or other stimulant-like drugs within 3 months; long-term steroids; and certain depression or movement-disorder medicines.
  • Past weight-loss surgery, anorexia or bulimia, or a high score on the study’s eating-problem test.
  • Certain serious mental health conditions, recent mental health hospital care, a suicide attempt within 2 years, self-harm within 3 months, or certain scores on depression or suicide-risk tests.
  • Recent use of an experimental medicine or device, another treatment study within 30 days, or another health problem or test result that could make joining unsafe or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria\* include, but are not limited to: * 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. Exclusion criteria\* include, but are not limited to: * 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; * Current nicotine use or nicotine cessation within 3 months of screening; * Stage 2 hypertension (or greater) or taking any medication to treat hypertension; * Current type 1 or type 2 diabetes mellitus or taking any medication to treat diabetes or prediabetes; * Current or recent (within 3 months of screening) use of prescribed weight loss medication(s)/medically prescribed diets (e.g., low calorie, meal replacement/herbal agents/dietary supplements or weight loss program); * Current or recent (within 3 months of screening) use of other sympathomimetic amines such as stimulants to treat attention- deficit/hyperactive disorder; * Use of chronic systemic glucocorticoid therapy (consecutive use of 3 months or more) or other steroid hormone therapy other than oral contraceptives; * Use of tricyclic antidepressants, lithium, levodopa, or dopamine receptor agonists; * History of bariatric surgery; * History or current diagnosis of schizophrenia, psychosis, bipolar disorder, or mental illness requiring hospitalization within 12 months of screening; * History of suicide attempt within 2 years or self-harm within 3 months of screening; * Current Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10; * Current suicidal ideation type 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS); * Current Eating Attitudes Test-26 (EAT-26) score ≥ 20 or any history of anorexia or bulimia. * Current condition or disease interfering with metabolism, such as untreated hypo- or hyperthyroidism, Cushing's syndrome; * Current clinically significant hepatic aspartate transaminase (AST) or alanine transaminase (ALT) \> 3x upper limit of age- and sex-specific normal range or renal disease (creatinine clearance \< 60 mL/minute); hypertriglyceridemia (triglyceride ≥ 400 mg/dL) or syndromic or monogenic obesity; * Any clinically significant abnormalities on a standard 12-lead electrocardiogram at baseline; * Heart rate \> 100 bpm at screening; * Current or recent use of any investigational medication or device or participation in an interventional clinical trial within 30 days of screening; * Any clinically significant medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation, investigational product administration, or interpretation of trial results.

Study sites (8)

DE

KY

LA

MO

NH

NM

OK

SC