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Can a common Weight-Loss pill help teens? new trial aims to find out

NCT ID NCT07282340

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

12 to 17 years

Sex

Anyone

Healthy volunteers

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

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.

obesity disorder Pediatric Obesity Weight Loss

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Pennington Biomedical Research Center

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Prisma Health-Midlands Children's Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • The University of Oklahoma Health Sciences Children's Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of New Mexico Health Sciences Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.