search
Back to results

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

Primary Purpose

Obesity

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Liraglutide
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide 3.0 mg

Placebo

Arm Description

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Outcomes

Primary Outcome Measures

Relative change in BMI (Body mass index)
Percent

Secondary Outcome Measures

Relative change in body weight
Percent
Change in BMI standard deviation score (WHO.int)
Unitless
Subjects achieving above or equal to 5 percent reduction of BMI
Yes/no
Subjects achieving above or equal to 10 percent reduction of BMI
Yes/no
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Percent point
Change in waist circumference
cm
Change in systolic blood pressure
mmHg
Change in diastolic blood pressure
mmHg
Change in HbA1c (glycated haemoglobin)
Percent point
Treatment emergent adverse events (TEAEs)
Number
Treatment emergent serious adverse events (SAEs
Number

Full Information

First Posted
February 26, 2021
Last Updated
September 20, 2023
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT04775082
Brief Title
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide 3.0 mg
Arm Type
Experimental
Arm Description
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
Primary Outcome Measure Information:
Title
Relative change in BMI (Body mass index)
Description
Percent
Time Frame
From baseline (week 0) to week 56
Secondary Outcome Measure Information:
Title
Relative change in body weight
Description
Percent
Time Frame
From baseline (week 0) to week 56
Title
Change in BMI standard deviation score (WHO.int)
Description
Unitless
Time Frame
From baseline (week 0) to week 56
Title
Subjects achieving above or equal to 5 percent reduction of BMI
Description
Yes/no
Time Frame
From baseline (week 0) to week 56
Title
Subjects achieving above or equal to 10 percent reduction of BMI
Description
Yes/no
Time Frame
From baseline (week 0) to week 56
Title
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Description
Percent point
Time Frame
From baseline (week 0) to week 56
Title
Change in waist circumference
Description
cm
Time Frame
From baseline (week 0) to week 56
Title
Change in systolic blood pressure
Description
mmHg
Time Frame
From baseline (week 0) to week 56
Title
Change in diastolic blood pressure
Description
mmHg
Time Frame
From baseline (week 0) to week 56
Title
Change in HbA1c (glycated haemoglobin)
Description
Percent point
Time Frame
From baseline (week 0) to week 56
Title
Treatment emergent adverse events (TEAEs)
Description
Number
Time Frame
From baseline (week 0) to week 82
Title
Treatment emergent serious adverse events (SAEs
Description
Number
Time Frame
From baseline (week 0) to week 82

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630048
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs