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Study · Randomized controlled trial · n = 24 · 2019

7 results

Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.

Mastrandrea LD, Witten L, Carlsson Petri KC, Hale PM, Hedman HK, Riesenberg RA

Pediatric obesity17 Jan 2019Cited by 63 (Europe PMC)

PMID30653847 (opens in a new tab)PMCIDPMC6590663 (opens in a new tab)DOI10.1111/ijpo.12495 (opens in a new tab)PepBankPUB-30653847
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In children aged 7 to 11 years with obesity, adverse event rates were similar with liraglutide and placebo; no test was reported.

    In plain wordsIn children with obesity, side effects were reported by a similar share of children on liraglutide and on placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeAdverse events
    Study

    n = 24

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Measurements

    Participants with adverse events
    56.3%
    liraglutide
    Participants with adverse events
    62.5%
    placebo

    Source sentences

    Summary
    Thirty-seven adverse events were reported in nine liraglutide-treated participants (56.3%) versus 12 events in five placebo-treated participants (62.5%).
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  2. 02HumanRandomized controlled trialSafety outcome

    In children aged 7 to 11 years with obesity, most adverse events were mild, three were moderate and none were severe.

    In plain wordsIn children with obesity, most side effects were mild and none were severe.

    Peptide
    Liraglutide
    Outcome
    Not applicableAdverse event severity
    Study

    n = 24

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Most adverse events were mild in severity, three were of moderate severity, and none were severe.
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  3. 03HumanRandomized controlled trialSafety outcome

    In children aged 7 to 11 years with obesity, gastrointestinal disorders occurred in more liraglutide-treated participants than placebo-treated participants.

    In plain wordsIn children with obesity, stomach and gut problems were more common with liraglutide than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseGastrointestinal disorders
    Study

    n = 24

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Measurements

    Participants with gastrointestinal disorders
    37.5%
    liraglutide
    Participants with gastrointestinal disorders
    12.5%
    placebo

    Source sentences

    Summary
    Gastrointestinal disorders were the most frequently reported events occurring in 37.5% of liraglutide-treated participants compared with placebo (12.5%).
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  4. 04HumanRandomized controlled trialSafety outcome

    In children aged 7 to 11 years with obesity, six asymptomatic hypoglycaemic episodes occurred in five participants, four of them liraglutide treated.

    In plain wordsIn children with obesity, six low blood sugar episodes without symptoms occurred in five children, four of them on liraglutide.

    Peptide
    Liraglutide
    Outcome
    Not applicableAsymptomatic hypoglycaemic episodes
    Study

    n = 24

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Six asymptomatic hypoglycaemic episodes occurred in five participants of whom four were liraglutide treated.
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  5. 05HumanRandomized controlled trialPharmacokinetics

    In children aged 7 to 11 years with obesity, liraglutide exposure was consistent with dose proportionality.

    In plain wordsIn children with obesity, the amount of liraglutide in the body rose in proportion to the dose.

    Peptide
    Liraglutide
    Outcome
    Not applicableLiraglutide exposure and dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Liraglutide exposure was consistent with dose proportionality.
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  6. 06HumanRandomized controlled trialPharmacokinetics

    In children aged 7 to 11 years with obesity, body weight was the only covariate to significantly affect liraglutide exposure.

    In plain wordsIn children with obesity, body weight was the only factor that clearly changed how much liraglutide was in the body.

    Peptide
    Liraglutide
    Outcome
    Not applicableCovariate effect on liraglutide exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Body weight was the only covariate to significantly impact exposure.
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…
  7. 07HumanRandomized controlled trialEfficacy outcome

    In children aged 7 to 11 years with obesity, liraglutide gave a significant reduction in BMI Z score from baseline to end of treatment.

    In plain wordsIn children with obesity, liraglutide lowered BMI Z score over the short trial.

    Peptide
    Liraglutide
    Outcome
    DecreaseBMI Z score change from baseline to end of treatment
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.3 mg start, weekly escalation up to 3.0 mg or maximum tolerated dose · subcutaneousAs given in this study (human).

    Measurements

    BMI Z score estimated treatment difference
    −0.28 Z score
    end of treatment

    Source sentences

    Summary
    A significant reduction in body mass index (BMI) Z score from baseline to end of treatment (estimated treatment difference: -0.28; P = 0.0062) was observed.
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled trial, 24 children received at least one dose of once-daily subcutaneous liraglutide (n = 16) or placebo (n = 8) starting at 0.3 mg with weekly dose escalations up to 3.0 mg or maximum tolerated dose, and 20 children completed the trial (14 in the…

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 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02696148

A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

Novo Nordisk A/Sn = 2414 Mar 2016 to 13 Apr 2017

Metabolism and Nutrition Disorder · Obesity

Trial pageClinicalTrials.govUpdated 18 Mar 2019

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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