DelfaGLP-1 Atlas

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Active not recruitingPhase 3

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

Effect and Safety of Liraglutide 3.0 mg on Weight Management in Children With Obesity Aged 6 to Below 12 Years: 56-week, Double-blind, Randomised, Placebo-controlled Trial

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

32

Recruiting sites

—

Enrollment

78

estimated

Study population

Obesity / overweight

Key I/E criterion

•Age 6-12

Primary endpoint

•BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04775082
Org study IDNN8022-4392
Secondary ID2020-000546-34European Medicines Agency (EudraCT)
Secondary IDU1111-1247-8226World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-03-01actual
Study start2021-03-04actual
Primary completion2023-08-01actual
Last update posted2026-05-22actual
Study completion2027-02-08estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age6 Years
Maximum age12 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
7
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Glycemic / diabetes
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Relative change in BMI (Body mass index)

Time frame:From baseline (week 0) to week 56

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to week 56

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI standard deviation score (WHO.int)

Time frame:From baseline (week 0) to week 56

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Subjects achieving above or equal to 5 percent reduction of BMI

Time frame:From baseline (week 0) to week 56

threshold achievement, improvement

Secondary/protocol endpoint

Subjects achieving above or equal to 10 percent reduction of BMI

Time frame:From baseline (week 0) to week 56

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)

Time frame:From baseline (week 0) to week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to week 56

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HbA1c (glycated haemoglobin)

Time frame:From baseline (week 0) to week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From baseline (week 0) to week 56

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From baseline (week 0) to week 56

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Treatment emergent adverse events (TEAEs)

Time frame:From baseline (week 0) to week 82

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Treatment emergent serious adverse events (SAEs

Time frame:From baseline (week 0) to week 82

Serious AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.