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Study · Randomized controlled trial · n = 21 · 2017

9 results

Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12-17 Years.

Danne T, Biester T, Kapitzke K, Jacobsen SH, Jacobsen LV, Petri KCC, Hale PM, Kordonouri O

The Journal of pediatrics13 Dec 2016Cited by 84 (Europe PMC)

PMID27979579 (opens in a new tab)DOI10.1016/j.jpeds.2016.10.076 (opens in a new tab)PepBankPUB-27979579
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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-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, all participants receiving liraglutide had at least 1 TEAE, versus 4 receiving placebo (57.1%); no statistical test is reported.

    In plain wordsIn adolescents with obesity, all on liraglutide had at least one side effect, compared with 4 of 7 on placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseParticipants with at least 1 treatment-emergent adverse event (TEAE)
    Study

    n = 21

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Measurements

    Participants with TEAE
    57.1%
    placebo

    Source sentences

    Summary
    All participants receiving liraglutide, and 4 receiving placebo (57.1%), had at least 1 TEAE.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  2. 02HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, the most common TEAEs were gastrointestinal disorders.

    In plain wordsIn adolescents with obesity, the most common side effects were stomach and gut problems.

    Peptide
    Liraglutide
    Outcome
    Not applicableMost common TEAE type
    Study

    n = 21

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common TEAEs were gastrointestinal disorders.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  3. 03HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, no severe TEAEs occurred.

    In plain wordsIn adolescents with obesity, no severe side effects occurred.

    Peptide
    Liraglutide
    Outcome
    No significant changeSevere TEAEs
    Study

    n = 21

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe TEAEs, TEAE-related withdrawals, or deaths occurred.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  4. 04HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, no TEAE-related withdrawals occurred.

    In plain wordsIn adolescents with obesity, no one left the trial because of side effects.

    Peptide
    Liraglutide
    Outcome
    No significant changeTEAE-related withdrawals
    Study

    n = 21

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe TEAEs, TEAE-related withdrawals, or deaths occurred.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  5. 05HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, no deaths occurred.

    In plain wordsIn adolescents with obesity, no one died.

    Peptide
    Liraglutide
    Outcome
    No significant changeDeaths
    Study

    n = 21

    Outcome group
    Mortality · Whole body
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe TEAEs, TEAE-related withdrawals, or deaths occurred.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  6. 06HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, 12 hypoglycaemic episodes occurred in 8 participants receiving liraglutide and 2 in 1 participant receiving placebo.

    In plain wordsIn adolescents with obesity, low blood sugar episodes were reported in 8 people on liraglutide and 1 on placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseHypoglycaemic episodes
    Study

    n = 21

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Measurements

    Hypoglycaemic episodes
    12 episodes
    liraglutide, 8 participants
    Hypoglycaemic episodes
    2 episodes
    placebo, 1 participant

    Source sentences

    Summary
    Twelve hypoglycemic episodes occurred in 8 participants receiving liraglutide and 2 in 1 participant receiving placebo.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  7. 07HumanRandomized controlled trialSafety outcome

    In adolescents with obesity, no severe hypoglycaemic episodes were reported.

    In plain wordsIn adolescents with obesity, no severe low blood sugar episodes were reported.

    Peptide
    Liraglutide
    Outcome
    No significant changeSevere hypoglycaemic episodes
    Study

    n = 21

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe hypoglycemic episodes were reported.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  8. 08HumanRandomized controlled trialPharmacokinetics

    In adolescents with obesity, liraglutide trough concentration increased with dose, but dose proportionality was confounded by unexpectedly low trough values at the 2.4 mg dose.

    In plain wordsIn adolescents with obesity, liraglutide blood levels rose with dose, though unexpectedly low levels at 2.4 mg blurred the pattern.

    Peptide
    Liraglutide
    Outcome
    IncreaseTrough concentration by dose
    Study

    n = 14

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Liraglutide exposure in terms of trough concentration increased with dose, although dose proportionality was confounded by unexpectedly low trough concentration values at the 2.4 mg dose.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)
  9. 09HumanRandomized controlled trialPharmacokinetics

    In adolescents with obesity, model-derived steady-state liraglutide exposure was similar to that in adults with obesity.

    In plain wordsIn adolescents with obesity, liraglutide exposure in the body was similar to that in adults with obesity.

    Peptide
    Liraglutide
    Outcome
    No significant changeModel-derived steady-state exposure (AUC 0-24 h)
    Study

    n = 14

    Comparator
    Adults with obesity
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.6 mg with weekly increase to a maximum of 3.0 mg · 5 weeksAs given in this study (human).

    Source sentences

    Summary
    Exposure in terms of model-derived area under the plasma concentration time curve from 0 to 24 hours after dose in steady state was similar to that in adults with obesity.
    1 context sentence
    Summary · context
    were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6 mg with weekly dose increase to a maximum of 3.0 mg for the last week) (n = 14) or placebo (n = 7)

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 1NCT01789086

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

Novo Nordisk A/Sn = 21Feb 2013 to May 2014

Metabolism and Nutrition Disorder · Obesity

Trial pageClinicalTrials.govUpdated 22 Dec 2016

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, 12:10 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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