NCT05416125

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for early_phase_1

Timeline
15mo left

Started Dec 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Dec 2023Jul 2027

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

June 8, 2022

Last Update Submit

January 7, 2026

Conditions

Obesity, Childhood

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Percent change in Body Mass Index

    The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24

    24 weeks

Study Arms (2)

Lifestyle therapy plus placebo

PLACEBO COMPARATOR

Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.

Behavioral: Lifestyle therapy

Lifestyle therapy plus lisdexamfetamine

ACTIVE COMPARATOR

Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.

Drug: Lisdexamfetamine Dimesylate

Interventions

Lisdexamfetamine DimesylateDRUG

Vyvanse treatment

Lifestyle therapy plus lisdexamfetamine
Lifestyle therapyBEHAVIORAL

Lifestyle treatment

Lifestyle therapy plus placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Claudia Fox, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

December 20, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)