Trial · Interventional

Active, not recruitingPhase 3Registry data

SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

NCTNCT04775082Other idNN8022-4392Other idU1111-1247-8226Other id2020-000546-34

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 78 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 9 countries
United States, Belgium, India, Israel, Malaysia, Mexico, Portugal, Russia, Switzerland
Start: 4 Mar 2021
Primary completion: 1 Aug 2023
Completion: 8 Feb 2027 (estimated)
First posted: 1 Mar 2021
Last update posted: 9 Jul 2026
Conditions: Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202420262028

Ph 3
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
NCT04775082
4 Mar 2021 to est. 8 Feb 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.

Interventions

LiraglutideDrug
PlaceboDrug

Arms2

Experimental
Liraglutide 3.0 mg
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Placebo comparator
Placebo
The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in BMI (Body mass index)
Time frame · From baseline (week 0) to week 56
Registry description
Percent

Secondary outcomes(11)

Relative change in body weight
Time frame · From baseline (week 0) to week 56
Registry description
Percent
Change in BMI standard deviation score (WHO.int)
Time frame · From baseline (week 0) to week 56
Registry description
Unitless
Subjects achieving above or equal to 5 percent reduction of BMI
Time frame · From baseline (week 0) to week 56
Registry description
Yes/no
Subjects achieving above or equal to 10 percent reduction of BMI
Time frame · From baseline (week 0) to week 56
Registry description
Yes/no
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Time frame · From baseline (week 0) to week 56
Registry description
Percent point
Change in waist circumference
Time frame · From baseline (week 0) to week 56
Registry description
cm
Change in systolic blood pressure
Time frame · From baseline (week 0) to week 56
Registry description
mmHg
Change in diastolic blood pressure
Time frame · From baseline (week 0) to week 56
Registry description
mmHg
Change in HbA1c (glycated haemoglobin)
Time frame · From baseline (week 0) to week 56
Registry description
Percent point
Treatment emergent adverse events (TEAEs)
Time frame · From baseline (week 0) to week 82
Registry description
Number
Treatment emergent serious adverse events (SAEs
Time frame · From baseline (week 0) to week 82
Registry description
Number

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

6 results

Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial.

Fox et al. 2025The New England journal of medicinecited by 103

PMID 39258838DOI 10.1056/nejmoa2407379PUB-39258838

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Years up to 12 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 6 to below 12 years at the time of signing informed consent * Tanner stage 1-5 pubertal development at the time of signing informed consent * BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov) * History of failing to lose sufficient weight with lifestyle modification as judged by the investigator For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition: \- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening Exclusion Criteria: * A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)

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