SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity (NCT04775082) — India Trial Details

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

LiraglutidePlacebo

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.

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

12 Years

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)

Primary outcome measure(s)

Relative change in BMI (Body mass index) — From baseline (week 0) to week 56
Percent

Trial sites (32)

Facility	City	Region
TMC Hlthcr Clin Res Office	Tucson	Arizona
Children's Hospital Colorado	Denver	Colorado
Solaris Clinical Research	Meridian	Idaho
Pennington Biom Res Ctr	Baton Rouge	Louisiana
Barry J. Reiner, MD LLC	Baltimore	Maryland
University of Minnesota_CPOM	Minneapolis	Minnesota
UBMD Peds-Div of Endo/Diabetes	Buffalo	New York
PriMed Clinical Research	Dayton	Ohio
UPMC Child Hosp-Pittsburgh	Pittsburgh	Pennsylvania
UZ Brussel	Brussels	Belgium
UZ Leuven - Kindergeneeskunde	Leuven	Belgium
Endolife Specialty Hospitals	Guntur	Andhra Pradesh
Mamc & Lnjp	New Delhi	India
Rambam MC - Department of Pediatrics A	Haifa	Israel
Schneider MC - Endrocrinology and Diabetes	Petah Tikva	Israel
University Malaya Medical Centre	Lembah Pantai	Kuala Lumpur
Hospital Putrajaya	Putrajaya	Malaysia
Consultorio de Endocrinología y Pediatría	Puebla City	Mexico
Hospital da Luz Lisboa, S.A.	Lisbon	Portugal
Hospital da Luz	Lisbon	Portugal
Centro Hospitalar Lisboa Norte	Lisbon	Portugal
Unidade De Santa Maria E.P.E. - Hospital de Santa Maria	Lisbon	Portugal
ULS De Santo António, E.P.E. - Hospital de Santo António	Porto	Portugal
Unidade Local de Saúde de Santo António, E.P.E	Porto	Portugal
CUF-Porto	Porto	Portugal
Hospital CUF Porto S.A.	Porto	Portugal
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia	Moscow	Russia
NSMU paediatric clinic	Novosibirsk	Russia
Samara Regional Children Clinical Hospital n.a. N.N. Ivanova	Samara	Russia
Siberian State Medical University	Tomsk	Russia
Kantonsspital Olten	Olten	Switzerland
Kinderspital Endokrinologie, Zürich	Zurich	Switzerland

On this site

📄 Victoza (liraglutide) drug profile →

More Novo Nordisk A/S trials in India

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors Active, not recruiting

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting

A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A Active, not recruiting

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease Recruiting

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting

Other trials for the same condition

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight Recruiting

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting

A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity Active, not recruiting

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin Recruiting