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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04775082
Recruitment Status : Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Liraglutide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
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
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : July 7, 2023
Estimated Study Completion Date : January 18, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide 3.0 mg
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Drug: Liraglutide

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 Comparator: Placebo
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Drug: Placebo
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.




Primary Outcome Measures :
  1. Relative change in BMI (Body mass index) [ Time Frame: From baseline (week 0) to week 56 ]
    Percent


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775082


Locations
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United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80045
United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83646
United States, Louisiana
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55414
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14203
United States, Ohio
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45419
United States, Pennsylvania
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
Belgium
Novo Nordisk Investigational Site
Brussel, Belgium, 1090
Novo Nordisk Investigational Site
Leuven, Belgium, 3000
India
Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, India, 522001
Novo Nordisk Investigational Site
New Delhi, India, 110002
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Malaysia
Novo Nordisk Investigational Site
Kuala Lumpur, Malaysia, 59100
Mexico
Novo Nordisk Investigational Site
Puebla, Mexico, 72190
Portugal
Novo Nordisk Investigational Site
Lisboa, Portugal, 1500-650
Novo Nordisk Investigational Site
Lisboa, Portugal, 1649-035
Novo Nordisk Investigational Site
Porto, Portugal, 4099-001
Novo Nordisk Investigational Site
Porto, Portugal, 4100-180
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117292
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630048
Novo Nordisk Investigational Site
Samara, Russian Federation, 443079
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634050
Switzerland
Novo Nordisk Investigational Site
Olten, Switzerland, 4600
Novo Nordisk Investigational Site
Zürich, Switzerland, 8032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 2834) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04775082    
Other Study ID Numbers: NN8022-4392
U1111-1247-8226 ( Other Identifier: World Health Organization (WHO) )
2020-000546-34 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists