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A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.
Pi-Sunyer, Xavier M.D.; Astrup, Arne M.D., D.M.Sc.; Fujioka, Ken M.D.; Greenway, Frank M.D.; Halpern, Alfredo M.D.; Krempf, Michel M.D., Ph.D.; Lau, David C.W. M.D., Ph.D.; le Roux, Carel W. F.R.C.P., Ph.D.; Violante Ortiz, Rafael M.D.; Jensen, Christine Bjorn M.D., Ph.D.; Wilding, John P.H. D.M.; the SCALE Obesity and Prediabetes NN8022-1839 Study Group *
[Article] New England Journal of Medicine. 373(1):11-22, July 2, 2015.

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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.)