ObesityPhase 3NCT04775082
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
A Phase 3 study testing Liraglutide in people with Obesity, run by Novo Nordisk A/S at 32 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 4 Mar 2021to 8 Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
32 sites in 9 countries.
32 sites in 9 countries
United States9 sites
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203
PriMed Clinical Research
Dayton, Ohio, 45419
Children's Hospital Colorado
Denver, Colorado, 80045
Solaris Clinical Research
Meridian, Idaho, 83646
University of Minnesota_CPOM
Minneapolis, Minnesota, 55414
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224
TMC Hlthcr Clin Res Office
Tucson, Arizona, 85712
Portugal8 sites
Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650
Hospital da Luz
Lisbon, 1500-650
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035
Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, 4099-001
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4099-001
CUF-Porto
Porto, 4100-180
Hospital CUF Porto S.A.
Porto, 4100-180
Russia4 sites
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, 117292
NSMU paediatric clinic
Novosibirsk, 630048
Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
Samara, 443079
Siberian State Medical University
Tomsk, 634050
Belgium2 sites
UZ Brussel
Brussels, 1090
UZ Leuven - Kindergeneeskunde
Leuven, 3000
India2 sites
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001
Mamc & Lnjp
New Delhi, 110002
Israel2 sites
Rambam MC - Department of Pediatrics A
Haifa, 31096
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, 49202
Malaysia2 sites
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Hospital Putrajaya
Putrajaya, 62250
Switzerland2 sites
Kantonsspital Olten
Olten, 4600
Kinderspital Endokrinologie, Zürich
Zurich, 8032
About this study
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
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.
Read more
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
- Being tested
- Liraglutide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
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.
PlaceboDrug
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | The treatment duration is 56 weeks and the follow-up period is 26 weeks. Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | The treatment duration is 56 weeks and the follow-up period is 26 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in BMI (Body mass index)
Percent
Measured: From baseline (week 0) to week 56
Secondary outcomes (11)
Relative change in body weight
Percent
Measured: From baseline (week 0) to week 56
Change in BMI standard deviation score (WHO.int)
Unitless
Measured: From baseline (week 0) to week 56
Subjects achieving above or equal to 5 percent reduction of BMI
Yes/no
Measured: From baseline (week 0) to week 56
Subjects achieving above or equal to 10 percent reduction of BMI
Yes/no
Measured: From baseline (week 0) to week 56
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Percent point
Measured: From baseline (week 0) to week 56
Change in waist circumference
cm
Measured: From baseline (week 0) to week 56
Change in systolic blood pressure
mmHg
Measured: From baseline (week 0) to week 56
Change in diastolic blood pressure
mmHg
Measured: From baseline (week 0) to week 56
Change in HbA1c (glycated haemoglobin)
Percent point
Measured: From baseline (week 0) to week 56
Treatment emergent adverse events (TEAEs)
Number
Measured: From baseline (week 0) to week 82
Treatment emergent serious adverse events (SAEs
Number
Measured: From baseline (week 0) to week 82
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start4 Mar 2021
- Primary completion1 Aug 2023
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775082
- Sponsor's protocol ID
- NN8022-4392
- Other IDs
- U1111-1247-8226, 2020-000546-34
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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.
PubMed 39258838