Clinical trial NCT04775082: SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Relative change in BMI (Body mass index)
timeFrame: From baseline (week 0) to week 56
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to week 56
measure: Change in BMI standard deviation score (WHO.int)
timeFrame: From baseline (week 0) to week 56
measure: Subjects achieving above or equal to 5 percent reduction of BMI
timeFrame: From baseline (week 0) to week 56
measure: Subjects achieving above or equal to 10 percent reduction of BMI
timeFrame: From baseline (week 0) to week 56
measure: BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
timeFrame: From baseline (week 0) to week 56
measure: Change in waist circumference
timeFrame: From baseline (week 0) to week 56
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to week 56
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to week 56
measure: Change in HbA1c (glycated haemoglobin)
timeFrame: From baseline (week 0) to week 56
measure: Treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to week 82
measure: Treatment emergent serious adverse events (SAEs
timeFrame: From baseline (week 0) to week 82
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Baton Rouge
country: United States
facility: Pennington Biom Res Ctr
state: Louisiana
city: Baltimore
country: United States
facility: Barry J. Reiner, MD LLC
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota_CPOM
state: Minnesota
city: Buffalo
country: United States
facility: UBMD Peds-Div of Endo/Diabetes
state: New York
city: Pittsburgh
country: United States
facility: UPMC Child Hosp-Pittsburgh
state: Pennsylvania
city: Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven - Kindergeneeskunde
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: New Delhi
country: India
facility: Mamc & Lnjp
city: Haifa
country: Israel
facility: Rambam Medical Center Children A Dept.
city: Petah Tikva
country: Israel
facility: Endrocrinology & DM Schneider MC
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Puebla
country: Mexico
facility: Consultorio de Endocrinología y Pediatría
city: Lisboa
country: Portugal
facility: Hospital Da Luz S.A.
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Santa Maria E.P.E.
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Porto
country: Portugal
facility: CUF-Porto
city: Porto
country: Portugal
facility: Hospital CUF Porto S.A.
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology
city: Novosibirsk
country: Russian Federation
facility: NSMU paediatric clinic
city: Samara
country: Russian Federation
facility: Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Zürich
country: Switzerland
facility: Kinderspital Endokrinologie, Zürich
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
citation: 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.