Could a common ADHD drug help kids with severe obesity?
NCT ID NCT05416125
First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 5 times
Summary
This study tests whether the drug lisdexamfetamine (Vyvanse), usually used for ADHD, can help children aged 6 to 12 with severe obesity lose weight. About 44 children will receive either the drug or a placebo, plus lifestyle therapy, for 24 weeks. The main goal is to see if their body mass index (BMI) improves.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lisdexamfetamine (Vyvanse)
- What this could lead to
- If it works, this could point toward a new treatment option for severe obesity in children who have not succeeded with lifestyle changes alone.
- What could go wrong
- This is a very early, small trial (44 kids) with no results yet. The drug may not work for weight loss in children, and side effects like decreased appetite or sleep problems are possible.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
44 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 12 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: * Children ages 6 to \<12 years at study entry * Severe obesity defined as BMI \>/= 1.2 times the 95th percentile at the screening visit * Prior failed attempt of lifestyle therapy per parent/guardian report * Written informed consent of parent/legal guardian and written assent of participant Exclusion Criteria: * Contraindications to lisdexamfetamine, including current or recent (\< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products * Family history of sudden death or ventricular arrhythmia in any first or second degree relative with any of the following: sudden or unexplained death including sudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantable defibrillator). * Any history of fainting or seizure from exercise, startle, or fright * Clinically significant congenital or structural heart disease or arrhythmia * BMI \<1.2 times the 95th percentile at the baseline/randomization visits * Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) \>/= 95th percentile (on 3 separate occasions) at the screening OR baseline/randomization visits * Tachycardia defined heart rate (HR) \>/= 120 bpm (on 3 separate occasions) at the screening OR baseline/randomization visits * Current or recent (\< 3 months) use of psychostimulant or sympathomimetic amine * History of chemical dependency * Diabetes mellitus (type 1 or 2) * Current or recent (\< 3 months) use of anti-obesity medication(s) * Previous bariatric surgery * Recent initiation or change in dose (\< 3 months prior) of anti-hypertensive or lipid medication(s) * Thyroid stimulating hormone (TSH) \> 1.5x upper limit of normal (ULN) * Aspartate transaminase (AST) or alanine transaminase (ALT) \> 3x ULN * Fasting glucose \>/= 126 mg/dL * History of mania, schizophrenia, bipolar disorder, or psychosis * Unstable depression or anxiety that has required hospitalization in the past 12 months * Any history of suicide attempt * Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh at the screening or baseline/randomization visits * Children's Depressive Inventory 2 (CDE-2\_ score \>/= 70 (based on parent or child report) at the screening or baseline/randomization visits * Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort at any time during the study * Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential * Inability to swallow test capsule (participants will have two opportunities)
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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.
Contacts and locations
Locations
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University of Minnesota
Minneapolis, Minnesota, 55414, United States
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