SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04775082 |
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Recruitment Status :
Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : April 24, 2024
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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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | March 4, 2021 |
| Actual Primary Completion Date : | August 1, 2023 |
| Estimated Study Completion Date : | January 15, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Liraglutide 3.0 mg
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
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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. |
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Placebo Comparator: Placebo
The treatment duration is 56 weeks and the follow-up period is 26 weeks.
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Drug: Placebo
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. |
- Relative change in BMI (Body mass index) [ Time Frame: From baseline (week 0) to week 56 ]Percent
- Relative change in body weight [ Time Frame: From baseline (week 0) to week 56 ]Percent
- Change in BMI standard deviation score (WHO.int) [ Time Frame: From baseline (week 0) to week 56 ]Unitless
- Subjects achieving above or equal to 5 percent reduction of BMI [ Time Frame: From baseline (week 0) to week 56 ]Yes/no
- Subjects achieving above or equal to 10 percent reduction of BMI [ Time Frame: From baseline (week 0) to week 56 ]Yes/no
- BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) [ Time Frame: From baseline (week 0) to week 56 ]Percent point
- Change in waist circumference [ Time Frame: From baseline (week 0) to week 56 ]cm
- Change in systolic blood pressure [ Time Frame: From baseline (week 0) to week 56 ]mmHg
- Change in diastolic blood pressure [ Time Frame: From baseline (week 0) to week 56 ]mmHg
- Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline (week 0) to week 56 ]Percent point
- Treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 82 ]Number
- Treatment emergent serious adverse events (SAEs [ Time Frame: From baseline (week 0) to week 82 ]Number
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years to 12 Years (Child) |
| 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775082
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| Study Director: | Clinical Transparency (dept. 2834) | Novo Nordisk A/S |
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT04775082 |
| Other Study ID Numbers: |
NN8022-4392 U1111-1247-8226 ( Other Identifier: World Health Organization (WHO) ) 2020-000546-34 ( Registry Identifier: European Medicines Agency (EudraCT) ) |
| First Posted: | March 1, 2021 Key Record Dates |
| Last Update Posted: | April 24, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | According to the Novo Nordisk disclosure commitment on novonordisk-trials.com |
| URL: | http://novonordisk-trials.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Obesity Overweight Overnutrition Nutrition Disorders Body Weight Liraglutide |
Glucagon-Like Peptide-1 Receptor Agonists Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |