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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT04775082

Run by

Novo Nordisk A/S

People needed

78

Starts

2021-03-04

Expected to finish

2027-02-08

Last updated by the study team

2026-07-09

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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
• 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

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)

Where it is running

• TMC Hlthcr Clin Res Office — Tucson, Arizona, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Pennington Biom Res Ctr — Baton Rouge, Louisiana, United States
• Barry J. Reiner, MD LLC — Baltimore, Maryland, United States
• University of Minnesota_CPOM — Minneapolis, Minnesota, United States
• UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States
• PriMed Clinical Research — Dayton, Ohio, United States
• UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States
• UZ Brussel — Brussels, Belgium
• UZ Leuven - Kindergeneeskunde — Leuven, Belgium
• Endolife Specialty Hospitals — Guntur, Andhra Pradesh, India
• Mamc & Lnjp — New Delhi, India
• Rambam MC - Department of Pediatrics A — Haifa, Israel
• Schneider MC - Endrocrinology and Diabetes — Petah Tikva, Israel
• University Malaya Medical Centre — Lembah Pantai, Kuala Lumpur, Malaysia
• Hospital Putrajaya — Putrajaya, Malaysia
• Consultorio de Endocrinología y Pediatría — Puebla City, Mexico
• Hospital da Luz Lisboa, S.A. — Lisbon, Portugal
• Hospital da Luz — Lisbon, Portugal
• Centro Hospitalar Lisboa Norte — Lisbon, Portugal
• Unidade De Santa Maria E.P.E. - Hospital de Santa Maria — Lisbon, Portugal
• ULS De Santo António, E.P.E. - Hospital de Santo António — Porto, Portugal
• Unidade Local de Saúde de Santo António, E.P.E — Porto, Portugal
• CUF-Porto — Porto, Portugal

Full record on ClinicalTrials.gov

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