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Phentermine for Childhood Obesity in Teens

This study is looking at how well a medication called phentermine works for weight loss in teenagers with obesity. Phentermine is a drug that helps with weight management. Participants aged 12 to 17 years who have obesity (a Body Mass Index, or BMI, at or above the 95th percentile for their age and sex, or a BMI of 30 kg/m2 or higher) may be able to join. You would take either phentermine (16 mg daily) or a placebo (an inactive pill that looks the same) for 52 weeks, along with lifestyle education. The main goal is to see how much your BMI changes from the beginning of the study to 52 weeks later. The study plans to enroll up to 240 participants, but the current recruitment status is unclear.

Study design
This is a Phase IIb, randomized, double-blind, placebo-controlled study involving up to 240 participants. You would be randomly assigned to receive either phentermine or a placebo.
What's involved
You would take a pill once daily for 52 weeks and receive lifestyle education handouts at each study visit. There will also be a 2-week period after treatment to assess withdrawal.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 52 weeks during the treatment period, with a 2-week withdrawal assessment afterward.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07282340

Phentermine's Impact on Treatment in Teens

Recruiting
PHASE2Ages 12–17InterventionalTreatment
Russell McCulloh, MD
~240 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:PhenterminePlacebo

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change in BMI from Baseline at Week 52
Measured over 52 weeks

Conditions

Childhood Obesity

Explore related trials

Obesity

Where it's being run

6 sites across 6 states
Louisiana1
Missouri1
New Hampshire1
New Mexico1
Oklahoma1
South Carolina1

Study leadership

  • Russell McCulloh, MD · STUDY_DIRECTOR · UNMC

Who to contact

Aubrey VanStory
[email protected]
402-559-4815
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent Change in BMI from Baseline at Week 5252 weeks

    Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.