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
Recruiting
CT.gov ID
NCT04775082
Collaborator
(none)
78
Enrollment
25
Locations
2
Arms
34
Anticipated Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteDenverColoradoUnited States80045
2Novo Nordisk Investigational SiteMeridianIdahoUnited States83646
3Novo Nordisk Investigational SiteBaton RougeLouisianaUnited States70808
4Novo Nordisk Investigational SiteBaltimoreMarylandUnited States21229
5Novo Nordisk Investigational SiteMinneapolisMinnesotaUnited States55414
6Novo Nordisk Investigational SiteBuffaloNew YorkUnited States14203
7Novo Nordisk Investigational SiteDaytonOhioUnited States45419
8Novo Nordisk Investigational SitePittsburghPennsylvaniaUnited States15224
9Novo Nordisk Investigational SiteBrusselBelgium1090
10Novo Nordisk Investigational SiteLeuvenBelgium3000
11Novo Nordisk Investigational SiteGunturAndhra PradeshIndia522001
12Novo Nordisk Investigational SiteNew DelhiIndia110002
13Novo Nordisk Investigational SiteHaifaIsrael31096
14Novo Nordisk Investigational SitePetah TikvaIsrael49202
15Novo Nordisk Investigational SiteKuala LumpurMalaysia59100
16Novo Nordisk Investigational SitePutrajayaMalaysia62250
17Novo Nordisk Investigational SitePueblaMexico72190
18Novo Nordisk Investigational SiteLisboaPortugal1649-035
19Novo Nordisk Investigational SitePortoPortugal4099-001
20Novo Nordisk Investigational SitePortoPortugal4100-180
21Novo Nordisk Investigational SiteMoscowRussian Federation117036
22Novo Nordisk Investigational SiteNovosibirskRussian Federation630048
23Novo Nordisk Investigational SiteSamaraRussian Federation443079
24Novo Nordisk Investigational SiteTomskRussian Federation634050
25Novo Nordisk Investigational SiteOltenSwitzerland4600

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), 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:
Nov 19, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Nov 19, 2021