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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04775082
• Other study ID #: NN8022-4392
• Secondary ID: U1111-1247-82262
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 4, 2021
• Est. completion date: January 15, 2027

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: January 15, 2027
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Belgium	UZ Leuven - Kindergeneeskunde	Leuven
India	Endolife Specialty Hospitals	Guntur	Andhra Pradesh
India	Mamc & Lnjp	New Delhi
Israel	Rambam Medical Center Children A Dept.	Haifa
Israel	Endrocrinology & DM Schneider MC	Petah Tikva
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Mexico	Consultorio de Endocrinología y Pediatría	Puebla
Portugal	Centro Hospitalar Lisboa Norte	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Centro Hospitalar do Porto, E.P.E	Porto
Portugal	CUF-Porto	Porto
Russian Federation	National Medical Research Center of Endocrinology	Moscow
Russian Federation	NSMU paediatric clinic	Novosibirsk
Russian Federation	Samara Regional Children Clinical Hospital n.a. N.N. Ivanova	Samara
Russian Federation	Siberian State Medical University	Tomsk
Switzerland	Kantonsspital Olten	Olten
Switzerland	Kinderspital Endokrinologie, Zürich	Zürich
United States	Barry J. Reiner, MD LLC	Baltimore	Maryland
United States	Pennington Biom Res Ctr	Baton Rouge	Louisiana
United States	UBMD Peds-Div of Endo/Diabetes	Buffalo	New York
United States	Children's Hospital Colorado	Denver	Colorado
United States	Solaris Clinical Research	Meridian	Idaho
United States	University of Minnesota_CPOM	Minneapolis	Minnesota
United States	UPMC Child Hosp-Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Belgium,  India,  Israel,  Malaysia,  Mexico,  Portugal,  Russian Federation,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in BMI (Body mass index)	Percent	From baseline (week 0) to week 56
Secondary	Relative change in body weight	Percent	From baseline (week 0) to week 56
Secondary	Change in BMI standard deviation score (WHO.int)	Unitless	From baseline (week 0) to week 56
Secondary	Subjects achieving above or equal to 5 percent reduction of BMI	Yes/no	From baseline (week 0) to week 56
Secondary	Subjects achieving above or equal to 10 percent reduction of BMI	Yes/no	From baseline (week 0) to week 56
Secondary	BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)	Percent point	From baseline (week 0) to week 56
Secondary	Change in waist circumference	cm	From baseline (week 0) to week 56
Secondary	Change in systolic blood pressure	mmHg	From baseline (week 0) to week 56
Secondary	Change in diastolic blood pressure	mmHg	From baseline (week 0) to week 56
Secondary	Change in HbA1c (glycated haemoglobin)	Percent point	From baseline (week 0) to week 56
Secondary	Treatment emergent adverse events (TEAEs)	Number	From baseline (week 0) to week 82
Secondary	Treatment emergent serious adverse events (SAEs	Number	From baseline (week 0) to week 82