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

Silvio Buscemi, Rafael Violante Ortiz, Christine Bjørn Jensen, Michel Krempf, John P.H. Wilding, Carel W. Le Roux, Xavier Pi-Sunyer, Frank Greenway, David C.W. Lau, Ken Fujioka, Alfredo Halpern, Arne Astrup

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Abstract

BACKGROUND: Obesity is a chronic disease with serious health consequences, butweight loss is difficult to maintain through lifestyle intervention alone.Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potentialbenefit for weight management at a once-daily dose of 3.0 mg, injectedsubcutaneously.METHODS: We conducted a 56-week, double-blind trial involving 3731 patients whodid not have type 2 diabetes and who had a body-mass index (BMI; the weight inkilograms 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 subcutaneousinjections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244patients); both groups received counseling on lifestyle modification. Thecoprimary end points were the change in body weight and the proportions ofpatients 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, themean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% ofthe patients were women and 61.2% had prediabetes. At week 56, patients in theliraglutide 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-forwardimputation). A total of 63.2% of the patients in the liraglutide group ascompared 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 bodyweight (P<0.001). The most frequently reported adverse events with liraglutidewere mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of thepatients in the liraglutide group and in 5.0% of the patients in the placebogroup.CONCLUSIONS: In this study, 3.0 mg of liraglutide, as an adjunct to diet andexercise, was associated with reduced body weight and improved metabolic control.(Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839ClinicalTrials.gov number, NCT01272219.).
Lingua originaleEnglish
pagine (da-a)11-22-22
Numero di pagine11
RivistaNew England Journal of Medicine
Volume373
Stato di pubblicazionePublished - 2015

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Buscemi, S., Ortiz, R. V., Jensen, C. B., Krempf, M., Wilding, J. P. H., Le Roux, C. W., Pi-Sunyer, X., Greenway, F., Lau, D. C. W., Fujioka, K., Halpern, A., & Astrup, A. (2015). A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. New England Journal of Medicine, 373, 11-22-22.