Evidence map›Paper›PMID 30653847›Full record

Trial reportPediatric obesity2019

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.

Lucy D Mastrandrea, Louise Witten, Kristin C Carlsson Petri, Paula M Hale, Hanna K Hedman, Robert A Riesenberg

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric obesity, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02696148. Cited by 35 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 9 pooled it
5.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02696148 phase1completed

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

Ran2016Enrolled24Registered outcomes2Posted comparisons0ConditionsMetabolism and Nutrition Disorder, ObesityArmsliraglutide, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 9 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. New Perspectives in Modulating the Entero-Insular Axis in Pediatric Obesity.International journal of molecular sciences · 2025
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Comparison of Pediatric and Adult Glucagon-Like Peptide-1 Receptor Agonist Exposures Reported To United States Poison Centers, 2017-2024.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2026
    Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Lucy D MastrandreaJacobs School of Medicine and Biomedical Sciences, Division of Pediatric Endocrinology/Diabetes, University at Buffalo, Buffalo, New York.ORCID 0000-0002-6031-0153
Louise WittenDepartment of Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
Kristin C Carlsson PetriDepartment of Quantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
Paula M HaleDepartment of Clinical Development, Novo Nordisk Inc, Plainsboro, New Jersey.
Hanna K HedmanDepartment of Safety Surveillance, Novo Nordisk A/S, Bagsvaerd, Denmark.
Robert A RiesenbergAtlanta Center for Medical Research, Atlanta, Georgia.
Novo Nordisk (Denmark) · DKAtlanta Medical Center · USJacobs Institute · USNovo Nordisk (United States) · US

Funding

Novo Nordisk A/S
6 · The paper itself

Abstract

backgroundChildhood obesity is a major public health concern with limited treatment options.

objectiveThe aim of this study was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics during short-term treatment with liraglutide in children (7-11 y) with obesity.

methodsIn 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 liraglutide group and six in the placebo group). The primary endpoint was the number of adverse events.

resultsBaseline characteristics (mean ± standard deviation) included the following: age 9.9 ± 1.1 years, weight 71.5 ± 15.4 kg, and 62.5% male. Thirty-seven adverse events were reported in nine liraglutide-treated participants (56.3%) versus 12 events in five placebo-treated participants (62.5%). Most adverse events were mild in severity, three were of moderate severity, and none were severe. Gastrointestinal disorders were the most frequently reported events occurring in 37.5% of liraglutide-treated participants compared with placebo (12.5%). Six asymptomatic hypoglycaemic episodes occurred in five participants of whom four were liraglutide treated. Liraglutide exposure was consistent with dose proportionality. Body weight was the only covariate to significantly impact exposure. 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.

conclusionShort-term treatment with liraglutide in children with obesity revealed a safety and tolerability profile similar to trials in adults and adolescents with obesity, with no new safety issues.

Indexed as

Body Mass IndexBody WeightChildDouble-Blind MethodFemaleHumansHypoglycemic AgentsLiraglutideMalePediatric ObesityTreatment OutcomeHypoglycemic AgentsLiraglutideClinical trialGLP-1liraglutidepaediatric

Identifiers

PMID30653847
PMCPMC6590663
OpenAlexW2909493990

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.