Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial.

Fox CK, Barrientos-Pérez M, Bomberg EM, Dcruz J, Gies I, Harder-Lauridsen NM, Jalaludin MY, Sahu K, Weimers P, Zueger T, Arslanian S

The New England journal of medicine10 Sept 2024Cited by 103 (Europe PMC)

PMID39258838DOI10.1056/nejmoa2407379PepBankPUB-39258838

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children aged 6 to under 12 years with obesity, liraglutide reduced BMI more than placebo at week 56.
In plain wordsIn children aged 6 to under 12 with obesity, liraglutide reduced BMI more than placebo with lifestyle care at 56 weeks.
Peptide
Liraglutide
Outcome
DecreasePercentage change in BMI at week 56
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
BMI change
−5.8%
liraglutide
BMI change
1.6%
placebo
Estimated difference
−7.4 percentage points
liraglutide versus placebo; 95% CI -11.6 to -3.2; P<0.001
Source sentences
Summary
At week 56, the mean percentage change from baseline in BMI was -5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of -7.4 percentage points (95% confidence interval [CI], -11.6 to -3.2; P<0.001).
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883801
02HumanRandomized controlled trialEfficacy outcome
In children aged 6 to under 12 years with obesity, liraglutide was associated with less body-weight gain than placebo at week 56.
In plain wordsIn children aged 6 to under 12 with obesity, weight increased less with liraglutide than placebo with lifestyle care at 56 weeks.
Peptide
Liraglutide
Outcome
DecreasePercentage change in body weight at week 56
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Body weight change
1.6%
liraglutide
Body weight change
10%
placebo
Estimated difference
−8.4 percentage points
liraglutide versus placebo; 95% CI -13.4 to -3.3; P = 0.001
Source sentences
Summary
The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of -8.4 percentage points (95% CI, -13.4 to -3.3; P = 0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of p…
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883802
03HumanRandomized controlled trialEfficacy outcome
In children aged 6 to under 12 years with obesity, more liraglutide-treated participants than placebo recipients achieved at least a 5% BMI reduction.
In plain wordsIn children aged 6 to under 12 with obesity, more achieved at least 5% BMI reduction with liraglutide than placebo plus lifestyle care.
Peptide
Liraglutide
Outcome
IncreaseBMI reduction of at least 5%
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Participants with BMI reduction at least 5%
46%
liraglutide
Participants with BMI reduction at least 5%
9%
placebo
Adjusted odds ratio
6.3
95% CI 1.4 to 28.8; P = 0.02
Source sentences
Summary
The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of -8.4 percentage points (95% CI, -13.4 to -3.3; P = 0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of p…
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883803
04HumanRandomized controlled trialSafety outcome
In children aged 6 to under 12 years with obesity receiving lifestyle care, adverse events were reported in 89% with liraglutide versus 88% with placebo; statistical comparison was unstated.
In plain wordsIn children aged 6 to under 12 with obesity, adverse events were reported in 89% with liraglutide versus 88% with placebo.
Peptide
Liraglutide
Outcome
IncreaseAny adverse event
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Adverse events
89%
liraglutide
Adverse events
88%
placebo
Source sentences
Summary
Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883804
05HumanRandomized controlled trialSafety outcome
In children aged 6 to under 12 years with obesity, gastrointestinal adverse events were more common with liraglutide than placebo.
In plain wordsIn children aged 6 to under 12 with obesity, digestive side effects were more common with liraglutide than placebo plus lifestyle care.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Gastrointestinal adverse events
80%
liraglutide
Gastrointestinal adverse events
54%
placebo
Source sentences
Summary
Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883805
06HumanRandomized controlled trialSafety outcome
In children aged 6 to under 12 years with obesity, serious adverse events were reported in 12% with liraglutide and 8% with placebo; statistical comparison was not stated.
In plain wordsIn children aged 6 to under 12 with obesity, serious adverse events were reported in 12% with liraglutide versus 8% with placebo.
Peptide
Liraglutide
Outcome
IncreaseSerious adverse events
Study
n = 82
Comparator
Placebo plus lifestyle interventions
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg or maximum tolerated dose once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Serious adverse events
12%
liraglutide
Serious adverse events
8%
placebo
Source sentences
Summary
Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or place…
Summary · context
The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters).
Summary · context
The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Summary · context
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group.
Report a problemFND-3925883806

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 3NCT04775082

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

Novo Nordisk A/Sn = 784 Mar 2021 to est. 8 Feb 2027

Obesity

Trial page ClinicalTrials.govUpdated 9 Jul 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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