Evidence map›Paper›PMID 21844879›Full record

Trial reportInternational journal of obesity (2005)2012

Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.

A Astrup, R Carraro, N Finer, A Harper, M Kunesova, M E J Lean, L Niskanen, M F Rasmussen, A Rissanen, S Rössner and 3 more

Erratum issued 5 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of obesity (2005), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT00422058. Cited by 278 papers, 28 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
278citing papers in PubMed, 28 pooled it
40.7field-weighted citation impact, top 1% 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.

NCT00422058 phase2completed

Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period

Ran2007Enrolled564Registered outcomes20Posted comparisons0ConditionsMetabolism and Nutrition Disorder, ObesityArmsliraglutide, Orlistat, Placebo
Open the trial in the graph
NCT01795248 phase4completed

The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus

Ran2012Enrolled105Registered outcomes18Posted comparisons0ConditionsGestational Diabetes MellitusArmsliraglutide, Placebo
Open the trial in the graph
NCT03038620 phase4completedstarted 2017, after this paper: background citation

Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease

Ran2017Enrolled235Registered outcomes37Posted comparisons0ConditionsCardiovascular Diseases, Fat Disorder, Obesity, VisceralArmsliraglutide, Placebo
Open the trial in the graph
NCT06132477 phase4recruitingstarted 2024, after this paper: background citation

Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric

Ran2024Enrolled150Registered outcomes5Posted comparisons0ConditionsDiabetes Mellitus, Hypertension, Metabolic Syndrome, Morbid ObesityArmsGLP-1 receptor agonist
Open the trial in the graph
NCT00480909 no registry record found
3 · Its place in the literature

Who cites it

278 citing papers in PubMed, 28 syntheses or guidelines pooled it, 742 citations in OpenAlex.

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  17. Obesity in South and Southeast Asia-A new consensus on care and management.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2023
    Guideline
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218 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
  • Erratum issued
5 · Who and what money

Authors and funding

13 authors at 8 institutions in 8 countries.

A AstrupDepartment of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Rolighedsvej 30, Frederiksberg C, Denmark. ast@life.ku.dk
R Carraro
N Finer
A Harper
M Kunesova
M E J Lean
L Niskanen
M F Rasmussen
A Rissanen
S Rössner
M J Savolainen
L Van Gaal
NN8022-1807 Investigators
Antwerp University Hospital · BEKarolinska University Hospital · SENovo Nordisk (Denmark) · DKUniversity of Copenhagen · DKUniversity of Eastern Finland · FIGlasgow Royal Infirmary · GBHelsinki University Hospital · FIHospital Universitario de La Princesa · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHaving demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.

designA randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers. SUBJECTS: A total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg, n=90-95), placebo (n=98) or open-label orlistat (120 mg × 3, n=95). After 1 year, liraglutide/placebo recipients switched to liraglutide 2.4 mg, then 3.0 mg (based on 20-week and 1-year results, respectively). The trial ran from January 2007-April 2009 and is registered with Clinicaltrials.gov, number NCT00480909.

resultsFrom randomization to year 1, liraglutide 3.0 mg recipients lost 5.8 kg (95% confidence interval 3.7-8.0) more weight than those on placebo and 3.8 kg (1.6-6.0) more than those on orlistat (P0.0001; intention-to-treat, last-observation-carried-forward). At year 2, participants on liraglutide 2.4/3.0 mg for the full 2 years (pooled group, n=184) lost 3.0 kg (1.3-4.7) more weight than those on orlistat (n=95; P<0.001). Completers on liraglutide 2.4/3.0 mg (n=92) maintained a 2-year weight loss of 7.8 kg from screening. With liraglutide 3.0 mg, 20-week body fat decreased by 15.4% and lean tissue by 2.0%. The most frequent drug-related side effects were mild to moderate, transient nausea and vomiting. With liraglutide 2.4/3.0 mg, the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59%, with improvements in blood pressure and lipids.

conclusionLiraglutide is well tolerated, sustains weight loss over 2 years and improves cardiovascular risk factors.

Indexed as

Weight LossAdolescentAdultAgedAnalysis of VarianceAnti-Obesity AgentsDouble-Blind MethodDrug Administration ScheduleEuropeExercise TherapyFemaleGlucagon-Like Peptide 1HumansLiraglutideMaleMiddle AgedAnti-Obesity AgentsGlucagon-Like Peptide 1Liraglutide

Identifiers

PMID21844879
PMCPMC3374073
OpenAlexW1994320162

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC-ND
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 OpenQuestion graph.