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

NCT04775082 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NN8022-4392U1111-1247-82262020-000546-34
• Study Type: interventional
• Target: 78
• Locations: 9 countries
• Sites: 31

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in BMI (Body mass index)

  Percent

  From baseline (week 0) to week 56

Secondary Outcomes (11)

• Relative change in body weight

  From baseline (week 0) to week 56

• Change in BMI standard deviation score (WHO.int)

  From baseline (week 0) to week 56

• Subjects achieving above or equal to 5 percent reduction of BMI

  From baseline (week 0) to week 56

• Subjects achieving above or equal to 10 percent reduction of BMI

  From baseline (week 0) to week 56

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

  From baseline (week 0) to week 56

Study Arms (2)

Liraglutide 3.0 mg

EXPERIMENTAL

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Drug: Placebo

Interventions

Liraglutide DRUG

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.

Liraglutide 3.0 mg

Placebo DRUG

The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• \- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (31)

TMC Hlthcr Clin Res Office

Tucson, Arizona, 85712, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Pennington Biom Res Ctr

Baton Rouge, Louisiana, 70808, United States

Location

Barry J. Reiner, MD LLC

Baltimore, Maryland, 21229, United States

Location

University of Minnesota_CPOM

Minneapolis, Minnesota, 55414, United States

Location

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, 14203, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven - Kindergeneeskunde

Leuven, 3000, Belgium

Location

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

Location

Mamc & Lnjp

New Delhi, 110002, India

Location

Rambam MC - Department of Pediatrics A

Haifa, 31096, Israel

Location

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, 49202, Israel

Location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Consultorio de Endocrinología y Pediatría

Puebla City, 72190, Mexico

Location

Hospital Da Luz S.A.

Lisbon, 1500-650, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar Lisboa Norte

Lisbon, 1649-035, Portugal

Location

Unidade Local De Saude De Santa Maria E.P.E.

Lisbon, 1649-035, Portugal

Location

Unidade Local de Saúde de Santo António, E.P.E

Porto, 4099-001, Portugal

Location

CUF-Porto

Porto, 4100-180, Portugal

Location

Hospital CUF Porto S.A.

Porto, 4100-180, Portugal

Location

FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

Moscow, 117292, Russia

Location

NSMU paediatric clinic

Novosibirsk, 630048, Russia

Location

Samara Regional Children Clinical Hospital n.a. N.N. Ivanova

Samara, 443079, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Kinderspital Endokrinologie, Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39258838 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 1, 2021
• Study Start: March 4, 2021
• Primary Completion: August 1, 2023
• Study Completion (Estimated): January 15, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (2); BE (2); IL (2); US (9); ME (1); MY (2); PT (7); RU (4); IN (2)