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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04775082
- Acronym / sponsor ID
- NN8022-4392
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 3.0 mg | Experimental | Drug: LiraglutideThe treatment duration is 56 weeks and the follow-up period is 26 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboThe treatment duration is 56 weeks and the follow-up period is 26 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideThe 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. | Drug | Liraglutide 3.0 mg |
| PlaceboThe study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. | Drug | Placebo |
Primary outcome
Relative change in BMI (Body mass index)
Time frame: From baseline (week 0) to week 56
Percent
11 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to week 56
Change in BMI standard deviation score (WHO.int)
Time frame: From baseline (week 0) to week 56
Subjects achieving above or equal to 5 percent reduction of BMI
Time frame: From baseline (week 0) to week 56
Subjects achieving above or equal to 10 percent reduction of BMI
Time frame: From baseline (week 0) to week 56
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 in waist circumference
Time frame: From baseline (week 0) to week 56
Change in systolic blood pressure
Time frame: From baseline (week 0) to week 56
Change in diastolic blood pressure
Time frame: From baseline (week 0) to week 56
Change in HbA1c (glycated haemoglobin)
Time frame: From baseline (week 0) to week 56
Treatment emergent adverse events (TEAEs)
Time frame: From baseline (week 0) to week 82
Treatment emergent serious adverse events (SAEs
Time frame: From baseline (week 0) to week 82
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 39258838Fox 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
32 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide in people with Obesity, run by Novo Nordisk A/S at 32 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Portugal, Russia, Belgium, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in BMI (Body mass index) (time frame: From baseline (week 0) to week 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.