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.).

• Authors: 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
• Journal: The New England journal of medicine (N Engl J Med) Vol. 373 Issue 1 Pg. 11-22 (Jul 02 2015) ISSN: 1533-4406 [Electronic] United States
• PMID: 26132939 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Hypoglycemic Agents
• Liraglutide
• Glucagon-Like Peptide 1

Topics

• Adult
• Blood Glucose (analysis)
• Body Mass Index
• Combined Modality Therapy
• Counseling
• Diarrhea (chemically induced)
• Diet, Reducing
• Double-Blind Method
• Exercise
• Female
• Glucagon-Like Peptide 1 (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects)
• Injections, Subcutaneous
• Liraglutide
• Male
• Middle Aged
• Nausea (chemically induced)
• Obesity (drug therapy, therapy)
• Weight Loss (drug effects)