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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Liraglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Leuven, Belgium, 3000
    • UZ Leuven - Kindergeneeskunde
• India
  • New Delhi, India, 110002
    • Mamc & Lnjp
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
• Israel
  • Haifa, Israel, 31096
    • Rambam MC - Department of Pediatrics A
  • Petah Tikva, Israel, 49202
    • Schneider MC - Endrocrinology and Diabetes
• Malaysia
  • Putrajaya, Malaysia, 62250
    • Hospital Putrajaya
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre
• Mexico
  • Puebla City, Mexico, 72190
    • Consultorio de Endocrinología y Pediatría
• Portugal
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz Lisboa, S.A.
  • Lisbon, Portugal, 1649-035
    • Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
  • Porto, Portugal, 4100-180
    • CUF-Porto
  • Porto, Portugal, 4099-001
    • Unidade Local de Saúde de Santo António, E.P.E
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto S.A.
  • Porto, Portugal, 4099-001
    • ULS De Santo António, E.P.E. - Hospital de Santo António
• Russia
  • Moscow, Russia, 117292
    • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
  • Novosibirsk, Russia, 630048
    • NSMU paediatric clinic
  • Samara, Russia, 443079
    • Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
  • Tomsk, Russia, 634050
    • Siberian State Medical University
• Switzerland
  • Olten, Switzerland, 4600
    • Kantonsspital Olten
  • Zurich, Switzerland, 8032
    • Kinderspital Endokrinologie, Zürich
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • TMC Hlthcr Clin Res Office
  • Colorado
    • Denver, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biom Res Ctr
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Barry J. Reiner, MD LLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota_CPOM
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Peds-Div of Endo/Diabetes
  • Ohio
    • Dayton, Ohio, United States, 45419
      • Primed Clinical Research
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Child Hosp-Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide 3.0 mg; The treatment duration is 56 weeks and the follow-up period is 26 weeks.	Drug: Liraglutide; The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. The dose will increase each week over 4 or 5 weeks until the final dose is reached.
Placebo Comparator: Placebo; The treatment duration is 56 weeks and the follow-up period is 26 weeks.	Drug: Placebo; The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in BMI (Body mass index)	Percent	From baseline (week 0) to week 56

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

General Publications

• Fox CK, Barrientos-Perez M, Bomberg EM, Dcruz J, Gies I, Harder-Lauridsen NM, Jalaludin MY, Sahu K, Weimers P, Zueger T, Arslanian S; SCALE Kids Trial Group. Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial. N Engl J Med. 2025 Feb 6;392(6):555-565. doi: 10.1056/NEJMoa2407379. Epub 2024 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Estimated): February 8, 2027

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gastrointestinal Hormones; Glucagon-Like Peptides; Proglucagon; Glucagon-Like Peptide 1; Liraglutide
• Other Study ID Numbers: NN8022-4392; U1111-1247-8226 (Other Identifier: World Health Organization (WHO)); 2020-000546-34 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No