Can a common Weight-Loss pill help teens? new trial aims to find out
NCT ID NCT07282340
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study tests whether a daily pill called phentermine helps teenagers aged 12 to 18 with obesity lose weight. About 240 teens will take either the drug or a placebo for 52 weeks. The main goal is to see how much their body mass index (BMI) changes, while also checking for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Mercy Hospital
RECRUITINGKansas City, Missouri, 64108, United States
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Dartmouth Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Pennington Biomedical Research Center
RECRUITINGBaton Rouge, Louisiana, 70808, United States
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Prisma Health-Midlands Children's Hospital
RECRUITINGColumbia, South Carolina, 29203, United States
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The University of Oklahoma Health Sciences Children's Hospital
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of New Mexico Health Sciences Center
RECRUITINGAlbuquerque, New Mexico, 87131, United States
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