Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.

ABSTRACT:

Objective

Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.

Design

A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.

Subjects

A total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-dail

SUBMITTER: Astrup A 

PROVIDER: S-EPMC3374073 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature