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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04775082
• Collaborator: (none)
• Enrollment: 78
• Locations: 26
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Liraglutide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 4, 2021
• Anticipated Primary Completion Date: Jul 7, 2023
• Anticipated Study Completion Date: Jan 4, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Relative change in BMI (Body mass index) [From baseline (week 0) to week 56]

   Percent

Secondary Outcome Measures

1. Relative change in body weight [From baseline (week 0) to week 56]

   Percent

2. Change in BMI standard deviation score (WHO.int) [From baseline (week 0) to week 56]

   Unitless

3. Subjects achieving above or equal to 5 percent reduction of BMI [From baseline (week 0) to week 56]

   Yes/no

4. Subjects achieving above or equal to 10 percent reduction of BMI [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) [From baseline (week 0) to week 56]

   Percent point

6. Change in waist circumference [From baseline (week 0) to week 56]

   cm

7. Change in systolic blood pressure [From baseline (week 0) to week 56]

   mmHg

8. Change in diastolic blood pressure [From baseline (week 0) to week 56]

   mmHg

9. Change in HbA1c (glycated haemoglobin) [From baseline (week 0) to week 56]

   Percent point

10. Treatment emergent adverse events (TEAEs) [From baseline (week 0) to week 82]

    Number

11. Treatment emergent serious adverse events (SAEs [From baseline (week 0) to week 82]

    Number

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Denver	Colorado	United States	80045
2	Novo Nordisk Investigational Site	Meridian	Idaho	United States	83646
3	Novo Nordisk Investigational Site	Baton Rouge	Louisiana	United States	70808
4	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21229
5	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55414
6	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
7	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45419
8	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
9	Novo Nordisk Investigational Site	Brussel		Belgium	1090
10	Novo Nordisk Investigational Site	Leuven		Belgium	3000
11	Novo Nordisk Investigational Site	Guntur	Andhra Pradesh	India	522001
12	Novo Nordisk Investigational Site	New Delhi		India	110002
13	Novo Nordisk Investigational Site	Haifa		Israel	31096
14	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
15	Novo Nordisk Investigational Site	Kuala Lumpur		Malaysia	59100
16	Novo Nordisk Investigational Site	Putrajaya		Malaysia	62250
17	Novo Nordisk Investigational Site	Puebla		Mexico	72190
18	Novo Nordisk Investigational Site	Lisboa		Portugal	1500-650
19	Novo Nordisk Investigational Site	Lisboa		Portugal	1649-035
20	Novo Nordisk Investigational Site	Porto		Portugal	4099-001
21	Novo Nordisk Investigational Site	Porto		Portugal	4100-180
22	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
23	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
24	Novo Nordisk Investigational Site	Samara		Russian Federation	443079
25	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
26	Novo Nordisk Investigational Site	Olten		Switzerland	4600

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04775082
• Other Study ID Numbers: NN8022-4392; U1111-1247-8226; 2020-000546-34
• First Posted: Mar 1, 2021
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Liraglutide

Study Results

No Results Posted as of Jun 9, 2022