Lifestyle therapy / Lisdexamfetamine Dimesylate / Obesity, Childhood · Phase EARLY_PHASE1 Trial

Vyvanse in Children Aged 6 to 12 Years

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed early-phase randomized controlled trial registration comparing lisdexamfetamine plus lifestyle therapy to placebo plus lifestyle therapy in 44 children with obesity. No outcome results are reported in this registry record, only the planned primary endpoint (percent change in BMI at 24 weeks).

What was studied

Early Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Childhood; age from 6 Years; to 12 Years; accepts healthy volunteers. Intervention: Lifestyle therapy plus lisdexamfetamine. Compared with: Lifestyle therapy plus placebo — Placebo Comparator. n = 44. 1 site: United States.

Key findings

Safety

Planned rather than actual outcome data; no power calculation, adverse event summary, or efficacy results provided.

Who this may help

Findings are not yet reported. When results are published, they will inform whether lisdexamfetamine combined with lifestyle intervention warrants further investigation for childhood obesity management.

Plain-language summary

Early-phase uncontrolled trial with small sample (n=44) examining lisdexamfetamine for childhood obesity; no results reported in registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percent change in Body Mass Index (assessed at 24 weeks)

DesignEarly Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Childhood; age from 6 Years; to 12 Years; accepts healthy volunteers

Sample size44

InterventionLifestyle therapy plus lisdexamfetamine

ComparatorLifestyle therapy plus placebo — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment44

Primary endpointPercent change in Body Mass Index

Follow-up duration24 weeks

PhaseEARLY_PHASE1

Clinical bottom line

Caveats

Results not reported in this registry record.
Early Phase 1 designation suggests this is an exploratory, not confirmatory, study.
Planned rather than actual outcome data; no power calculation, adverse event summary, or efficacy results provided.
Generalizability limited by small sample size and early-phase status.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized, placebo-controlled, but Early Phase 1 designation limits interpretive scope.

Directness

moderate

Directly examines lisdexamfetamine in children with obesity; surrogate endpoint (BMI change).

Consistency

insufficient

Registry record alone; no comparative data or prior results cited.

Risk of bias

insufficient

Blinding and allocation concealment not stated in registry record.

Sample adequacy

limited

Actual enrollment 44 participants; power calculation not reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05416125). This is a study registration, not published results. Lead sponsor: University of Minnesota. Recruitment status: COMPLETED. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 44 participants (ACTUAL). Conditions: Obesity, Childhood. Interventions: DRUG: Lisdexamfetamine Dimesylate; BEHAVIORAL: Lifestyle therapy. Primary outcome measures: Percent change in Body Mass Index , 24 weeks. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05416125University of MinnesotaLifestyle therapyLisdexamfetamine DimesylateObesity, Childhood