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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-8226 | Other Identifier | World Health Organization (WHO) | |
| 2020-000546-34 | Registry Identifier | European Medicines Agency (EudraCT) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 3.0 mg | Experimental | The treatment duration is 56 weeks and the follow-up period is 26 weeks. |
|
| Placebo | Placebo Comparator | The treatment duration is 56 weeks and the follow-up period is 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in BMI (Body mass index) | Percent | From baseline (week 0) to week 56 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TMC Hlthcr Clin Res Office | Tucson | Arizona | 85712 | United States | ||
| Children's Hospital Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39258838 | Result | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo | Drug | The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. |
|
| 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 |
| Denver |
| Colorado |
| 80045 |
| United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Pennington Biom Res Ctr | Baton Rouge | Louisiana | 70808 | United States |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | United States |
| University of Minnesota_CPOM | Minneapolis | Minnesota | 55414 | United States |
| UBMD Peds-Div of Endo/Diabetes | Buffalo | New York | 14203 | United States |
| PriMed Clinical Research | Dayton | Ohio | 45419 | United States |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| UZ Brussel | Brussels | 1090 | Belgium |
| UZ Leuven - Kindergeneeskunde | Leuven | 3000 | Belgium |
| Endolife Specialty Hospitals | Guntur | Andhra Pradesh | 522001 | India |
| Mamc & Lnjp | New Delhi | 110002 | India |
| Rambam MC - Department of Pediatrics A | Haifa | 31096 | Israel |
| Schneider MC - Endrocrinology and Diabetes | Petah Tikva | 49202 | Israel |
| University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Putrajaya | Putrajaya | 62250 | Malaysia |
| Consultorio de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Hospital da Luz Lisboa, S.A. | Lisbon | 1500-650 | Portugal |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar Lisboa Norte | Lisbon | 1649-035 | Portugal |
| Unidade De Santa Maria E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| ULS De Santo António, E.P.E. - Hospital de Santo António | Porto | 4099-001 | Portugal |
| Unidade Local de Saúde de Santo António, E.P.E | Porto | 4099-001 | Portugal |
| CUF-Porto | Porto | 4100-180 | Portugal |
| Hospital CUF Porto S.A. | Porto | 4100-180 | Portugal |
| FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia | Moscow | 117292 | Russia |
| NSMU paediatric clinic | Novosibirsk | 630048 | Russia |
| Samara Regional Children Clinical Hospital n.a. N.N. Ivanova | Samara | 443079 | Russia |
| Siberian State Medical University | Tomsk | 634050 | Russia |
| Kantonsspital Olten | Olten | 4600 | Switzerland |
| Kinderspital Endokrinologie, Zürich | Zurich | 8032 | Switzerland |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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