Cited by 2,724Pharmacology and Obesity TreatmentDiabetes Treatment and ManagementRegulation of Appetite and Obesity

The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management

Open access
Pi-Sunyer, Xavier, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Halpern, Alfredo, Krempf, Michel, Lau, David C.W., le Roux, Carel W., Violante Ortiz, Rafael, Jensen, Christine Bjørn, Wilding, John P.H.·2015·New England Journal of Medicine

Abstract

BACKGROUND: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS: At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS: In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.).

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  1. Tenner S, 1994, Am J Gastroenterol, 89, 1863
  2. National Academy of Sciences. The prevention and treatment of missing data in clinical trials. Washington, DC: National Academies Press, 2010.

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Metadata

Authors
Pi-Sunyer, X., Astrup, A., Fujioka, K., Greenway, F., Halpern, A., Krempf, M., Lau, D. C. W., le Roux, C. W., Violante Ortiz, R., Jensen, C. B., & Wilding, J. P. H.
Affiliations
  • University College Dublin (IE)
  • University of Copenhagen (DK)
  • Scripps Clinic (US)
  • Pennington Biomedical Research Center (US)
  • Universidade de São Paulo (BR)
  • Centre Hospitalier Universitaire de Nantes (FR)
  • University of Calgary (CA)
  • Novo Nordisk (Denmark) (DK)
  • University of Liverpool (GB)
Venue
New England Journal of Medicine
Published
2015-07-02
Volume
373
Issue
1
Pages
11-22
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W807162506
Cited by
2,724
References
31
Citations by year
2026: 353 · 2025: 450 · 2024: 399 · 2023: 316 · 2022: 209 · 2021: 234 · 2020: 160 · 2019: 145 · 2018: 145 · 2017: 140 · 2016: 140 · 2015: 31
FWCI
109.67
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
  • HAL (submittedVersion)
  • CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion, other-oa)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
  • Florence Research (University of Florence) (submittedVersion)
  • Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
Funders
National Institute of Diabetes and Digestive and Kidney Diseases (P30DK026687)
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
Keywords
liraglutide, obesity, weight loss, GLP-1 receptor agonists, lifestyle modification, prediabetes, adverse events, nausea, diarrhea, drug safety, weight management, subcutaneous injection, dyslipidemia, type 2 diabetes prevention, long-term weight maintenance, body mass index
MeSH terms
Liraglutide, Adult, Blood Glucose, Combined Modality Therapy, Counseling, Diarrhea, Diet, Reducing, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Male, Middle Aged, Nausea, Obesity, Weight Loss, Exercise, Body Mass Index, Glucagon-Like Peptide 1

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