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Study · Randomized controlled trial · n = 251 · 2020

11 results

A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.

Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S

The New England journal of medicine31 Mar 2020Cited by 520 (Europe PMC)

PMID32233338 (opens in a new tab)DOI10.1056/nejmoa1916038 (opens in a new tab)PepBankPUB-32233338
Publisher pagePubMedAsk about this study
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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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, liraglutide 3.0 mg reduced the BMI standard-deviation score more than placebo at week 56, in addition to lifestyle therapy.

    In plain wordsIn adolescents with obesity, liraglutide lowered BMI score more than placebo at week 56, with lifestyle therapy for both groups.

    Peptide
    Liraglutide
    Outcome
    DecreaseBMI standard-deviation score change at week 56
    Study

    n = 251

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Estimated difference in BMI SDS
    −0.22 SDS
    liraglutide vs placebo

    Source sentences

    Summary
    Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 (estimated difference, -0.22; 95% confidence interval [CI], -0.37 to -0.08; P = 0.002).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, liraglutide reduced BMI more than placebo.

    In plain wordsIn adolescents with obesity, liraglutide lowered BMI more than placebo.

    Peptide
    Liraglutide
    Outcome
    DecreaseBMI change
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Estimated difference in BMI
    −4.64 percentage points
    liraglutide vs placebo

    Source sentences

    Summary
    A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, liraglutide reduced body weight in kilograms more than placebo.

    In plain wordsIn adolescents with obesity, liraglutide lowered body weight more than placebo.

    Peptide
    Liraglutide
    Outcome
    DecreaseBody weight absolute change
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Estimated difference in body weight
    −4.5 kg
    liraglutide vs placebo

    Source sentences

    Summary
    A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, liraglutide reduced body weight in percentage points more than placebo.

    In plain wordsIn adolescents with obesity, liraglutide lowered body weight by a larger percentage than placebo.

    Peptide
    Liraglutide
    Outcome
    DecreaseBody weight relative change
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Estimated difference in relative body weight
    −5.01 percentage points
    liraglutide vs placebo

    Source sentences

    Summary
    A greater reduction was observed with liraglutide than with placebo for BMI (estimated difference, -4.64 percentage points) and for body weight (estimated difference, -4.50 kg [for absolute change] and -5.01 percentage points [for relative change]).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  5. 05HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, more participants had gastrointestinal adverse events with liraglutide than with placebo.

    In plain wordsIn adolescents with obesity, more participants had stomach and gut side effects with liraglutide than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Participants with GI adverse events
    64.8%
    liraglutide
    Participants with GI adverse events
    36.5%
    placebo

    Source sentences

    Summary
    More participants in the liraglutide group than in the placebo group had gastrointestinal adverse events (81 of 125 [64.8%] vs. 46 of 126 [36.5%])
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  6. 06HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, more participants stopped treatment because of adverse events with liraglutide than with placebo.

    In plain wordsIn adolescents with obesity, more participants stopped treatment because of side effects with liraglutide than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseAdverse events leading to discontinuation
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Discontinuation due to adverse events
    10.4%
    liraglutide
    Discontinuation due to adverse events
    0 n
    placebo

    Source sentences

    Summary
    adverse events that led to discontinuation of the trial treatment (13 [10.4%] vs. 0).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  7. 07HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, few participants in either the liraglutide or the placebo group had serious adverse events.

    In plain wordsIn adolescents with obesity, few participants had serious side effects, in either the liraglutide or the placebo group.

    Peptide
    Liraglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Serious adverse events
    2.4%
    liraglutide
    Serious adverse events
    4%
    placebo

    Source sentences

    Summary
    Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  8. 08HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, one suicide occurred in the liraglutide group; the investigator assessed it as unlikely to be related to the trial treatment.

    In plain wordsIn adolescents with obesity, one suicide occurred in the liraglutide group; the investigator judged it unlikely to be related to treatment.

    Peptide
    Liraglutide
    Outcome
    Not applicableSuicide
    Study

    n = 251

    Comparator
    Placebo
    Outcome group
    Adverse events · Mental health and mood
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Source sentences

    Summary
    One suicide, which occurred in the liraglutide group, was assessed by the investigator as unlikely to be related to the trial treatment.
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  9. 09HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, more participants had a BMI reduction of at least 5% with liraglutide than with placebo.

    In plain wordsIn adolescents with obesity, more participants lost at least 5% of BMI with liraglutide than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseBMI reduction of at least 5%
    Study

    n = 218

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Responders BMI reduction >=5%
    43.3%
    liraglutide
    Responders BMI reduction >=5%
    18.7%
    placebo

    Source sentences

    Summary
    A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  10. 10HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, more participants had a BMI reduction of at least 10% with liraglutide than with placebo.

    In plain wordsIn adolescents with obesity, more participants lost at least 10% of BMI with liraglutide than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseBMI reduction of at least 10%
    Study

    n = 218

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Responders BMI reduction >=10%
    26.1%
    liraglutide
    Responders BMI reduction >=10%
    8.1%
    placebo

    Source sentences

    Summary
    A reduction in BMI of at least 5% was observed in 51 of 113 participants in the liraglutide group and in 20 of 105 participants in the placebo group (estimated percentage, 43.3% vs. 18.7%), and a reduction in BMI of at least 10% was observed in 33 and 9, respectively (estimated percentage, 26.1% vs. 8.1%).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…
  11. 11HumanRandomized controlled trialEfficacy outcome

    In adolescents with obesity, the BMI standard-deviation score rose more after stopping liraglutide than after stopping placebo.

    In plain wordsIn adolescents with obesity, BMI score went up more after stopping liraglutide than after stopping placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseBMI standard-deviation score change after discontinuation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg · subcutaneous · 56 weeksAs given in this study (human).

    Measurements

    Estimated difference in BMI SDS
    0.15 SDS
    liraglutide vs placebo, after discontinuation

    Source sentences

    Summary
    After discontinuation, a greater increase in the BMI standard-deviation score was observed with liraglutide than with placebo (estimated difference, 0.15; 95% CI, 0.07 to 0.23).
    1 context sentence
    Summary · context
    In this randomized, double-blind trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we enrolled adolescents (12 to <18 years of age) with obesity and a poor response to lifestyle therapy alone. Participants were randomly assigned (1:1) to receive either liraglutide…

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

Registered trials3

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

3 trials · 1 ongoing · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 4NCT07590219

Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

University of Sao Paulo General Hospitaln = 3030 Mar 2024 to est. Apr 2028

Severe Obesity · Cardiovascular Function · Liraglutide · Childhood Obesity · Echocardiography · Speckle Tracking

Trial pageClinicalTrials.govUpdated 15 May 2026
CompletedPhase 2Results postedNCT04883346

Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)n = 3421 Jun 2021 to 30 Apr 2024

Obesity · Status Post Sleeve Gastrectomy

Trial pageClinicalTrials.govUpdated 20 Nov 2024
CompletedPhase 3Results postedNCT02918279

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Novo Nordisk A/Sn = 25129 Sept 2016 to 8 Aug 2019

Metabolism and Nutrition Disorder · Obesity

Trial pageClinicalTrials.govUpdated 27 Apr 2020

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.

  1. Version 2Current

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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