Obesity, ChildhoodEarly Phase 1NCT05416125
Vyvanse in Children Aged 6 to 12 Years
A Early Phase 1 study testing Lisdexamfetamine Dimesylate and Lifestyle therapy in people with Obesity, Childhood, run by University of Minnesota at 1 site in United States.
Trial summary
This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Lisdexamfetamine Dimesylate and Lifestyle therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 23 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.
Read the detailed description
This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.
- Conditions
- Obesity, Childhood
- Being tested
- Lisdexamfetamine Dimesylate, Lifestyle therapy
- Keywords
- Obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisdexamfetamine DimesylateDrug
Vyvanse treatment
Lifestyle therapyBehavioural
Lifestyle treatment
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle therapy plus placebo | Placebo comparator | Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks. Receives: Behavioral: Lifestyle therapy |
| Lifestyle therapy plus lisdexamfetamine | Active comparator | Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks. Receives: Drug: Lisdexamfetamine Dimesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Body Mass Index
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start20 Dec 2023
- Primary completion23 Jun 2026
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Fox, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416125
- Sponsor's protocol ID
- PEDS-2022-30981
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
- ClinicalTrials.gov ID
- NCT05416125
- Acronym / sponsor ID
- PEDS-2022-30981
- Conditions
- Obesity, Childhood
- Keywords
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.
Detailed description
This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle therapy plus placebo | Placebo comparator | Behavioral: Lifestyle therapyIndividuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks. |
| Lifestyle therapy plus lisdexamfetamine | Active comparator | Drug: Lisdexamfetamine DimesylateIndividuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisdexamfetamine DimesylateVyvanse treatment | Drug | Lifestyle therapy plus lisdexamfetamine |
| Lifestyle therapyLifestyle treatment | Behavioural | Lifestyle therapy plus placebo |
Primary outcome
Percent change in Body Mass Index
Time frame: 24 weeks
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Fox, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lisdexamfetamine Dimesylate and Lifestyle therapy in people with Obesity, Childhood, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in Body Mass Index (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.