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NCT Number: NCT04775082

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Brussel, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Drug

The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.

Primary outcomes

  1. Relative change in BMI (Body mass index)

    Time frame: From baseline (week 0) to week 56

    Percent

Secondary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to week 56

    Percent

  2. Change in BMI standard deviation score (WHO.int)

    Time frame: From baseline (week 0) to week 56

    Unitless

  3. Subjects achieving above or equal to 5 percent reduction of BMI

    Time frame: From baseline (week 0) to week 56

    Yes/no

  4. Subjects achieving above or equal to 10 percent reduction of BMI

    Time frame: From baseline (week 0) to week 56

    Yes/no

  5. BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)

    Time frame: From baseline (week 0) to week 56

    Percent point

  6. Change in waist circumference

    Time frame: From baseline (week 0) to week 56

    cm

  7. Change in systolic blood pressure

    Time frame: From baseline (week 0) to week 56

    mmHg

  8. Change in diastolic blood pressure

    Time frame: From baseline (week 0) to week 56

    mmHg

  9. Change in HbA1c (glycated haemoglobin)

    Time frame: From baseline (week 0) to week 56

    Percent point

  10. Treatment emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to week 82

    Number

  11. Treatment emergent serious adverse events (SAEs

    Time frame: From baseline (week 0) to week 82

    Number

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Mar 1, 2021
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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