Childhood Obesity study: Phentermine
Official title Phentermine's Impact on Treatment in Teens
ClinicalTrials.gov ID: NCT07282340
What this study is testing
What is Phentermine?
An investigational oral medicine being studied for weight loss in adolescents with obesity. It is designed to reduce appetite by increasing norepinephrine activity in the brain.
Also referred to as Adipex-P, Ionamin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn whether phentermine is safe and effective for reducing obesity in adolescents.
- Who it's for
- Teens 12 to under 18 years old who have obesity.
- What's involved
- Participants take one pill each day for 52 weeks, not knowing if it’s the drug or a placebo, and attend regular clinic visits, ending with a 2‑week withdrawal check.
- Time commitment
- About one year of daily medication and scheduled visits, plus a final 2‑week follow‑up.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join 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...
You likely can't join if
- A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant...
- 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;
See the full eligibility criteria
- 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.
- 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)
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Wilmington, Delaware, United States
- Louisville, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Kansas City, Missouri, United States
- Lebanon, New Hampshire, United States
- Albuquerque, New Mexico, United States
- Oklahoma City, Oklahoma, United States
- Columbia, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Wilmington, Delaware, United States; Louisville, Kentucky, United States; Baton Rouge, Louisiana, United States; Kansas City, Missouri, United States; Lebanon, New Hampshire, United States; Albuquerque, New Mexico, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.