A randomized, controlled trial of 3.0 mg of Liraglutide in weight management

Xavier Pi-Sunyer; Arne Astrup; Ken Fujioka; Frank Greenway; Alfredo Halpern; Michel Krempf; David C W Lau; Carel W le Roux; Rafael Violante Ortiz; Christine Bjørn Jensen; John P H Wilding; SCALE Obesity and Prediabetes NN8022-1839 Study Group

doi:10.1056/nejmoa1411892

A randomized, controlled trial of 3.0 mg of Liraglutide in weight management

Xavier Pi-Sunyer, Arne Astrup, Ken Fujioka, Frank Greenway, Alfredo Halpern, Michel Krempf, David C W Lau, Carel W le Roux, Rafael Violante Ortiz, Christine Bjørn Jensen, John P H Wilding, SCALE Obesity and Prediabetes NN8022-1839 Study Group

Obesity Research

726 Citations (Scopus)

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 .).

Original language	English
Journal	New England Journal of Medicine
Volume	373
Issue number	1
Pages (from-to)	11-22
Number of pages	12
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1411892
Publication status	Published - 2 Jul 2015

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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., & SCALE Obesity and Prediabetes NN8022-1839 Study Group (2015). A randomized, controlled trial of 3.0 mg of Liraglutide in weight management. New England Journal of Medicine, 373(1), 11-22. https://doi.org/10.1056/nejmoa1411892

Pi-Sunyer, X, Astrup, A, Fujioka, K, Greenway, F, Halpern, A, Krempf, M, Lau, DCW, le Roux, CW, Violante Ortiz, R, Jensen, CB, Wilding, JPH & SCALE Obesity and Prediabetes NN8022-1839 Study Group 2015, 'A randomized, controlled trial of 3.0 mg of Liraglutide in weight management', New England Journal of Medicine, vol. 373, no. 1, pp. 11-22. https://doi.org/10.1056/nejmoa1411892

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title = "A randomized, controlled trial of 3.0 mg of Liraglutide in weight management",

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 .).",

author = "Xavier Pi-Sunyer and Arne Astrup and Ken Fujioka and Frank Greenway and Alfredo Halpern and Michel Krempf and Lau, {David C W} and {le Roux}, {Carel W} and {Violante Ortiz}, Rafael and Jensen, {Christine Bj{\o}rn} and Wilding, {John P H} and {SCALE Obesity and Prediabetes NN8022-1839 Study Group}",

note = "CURIS 2015 NEXS 232",

year = "2015",

month = jul,

day = "2",

doi = "10.1056/nejmoa1411892",

language = "English",

volume = "373",

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journal = "New England Journal of Medicine",

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TY - JOUR

T1 - A randomized, controlled trial of 3.0 mg of Liraglutide in weight management

AU - Pi-Sunyer, Xavier

AU - Astrup, Arne

AU - Fujioka, Ken

AU - Greenway, Frank

AU - Halpern, Alfredo

AU - Krempf, Michel

AU - Lau, David C W

AU - le Roux, Carel W

AU - Violante Ortiz, Rafael

AU - Jensen, Christine Bjørn

AU - Wilding, John P H

AU - SCALE Obesity and Prediabetes NN8022-1839 Study Group

N1 - CURIS 2015 NEXS 232

PY - 2015/7/2

Y1 - 2015/7/2

N2 - 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 .).

AB - 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 .).

U2 - 10.1056/nejmoa1411892

DO - 10.1056/nejmoa1411892

M3 - Journal article

C2 - 26132939

SN - 0028-4793

VL - 373

SP - 11

EP - 22

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 1

ER -

A randomized, controlled trial of 3.0 mg of Liraglutide in weight management

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