IMPORTANCE: Weight loss of 5% to 10% can improve type 2 diabetes and related 
comorbidities. Few safe, effective weight-management drugs are currently 
available.
OBJECTIVE: To investigate efficacy and safety of liraglutide vs placebo for 
weight management in adults with overweight or obesity and type 2 diabetes.
DESIGN, SETTING, AND PARTICIPANTS: Fifty-six-week randomized (2:1:1), 
double-blind, placebo-controlled, parallel-group trial with 12-week 
observational off-drug follow-up period. The study was conducted at 126 sites in 
9 countries between June 2011 and January 2013. Of 1361 participants assessed 
for eligibility, 846 were randomized. Inclusion criteria were body mass index of 
27.0 or greater, age 18 years or older, taking 0 to 3 oral hypoglycemic agents 
(metformin, thiazolidinedione, sulfonylurea) with stable body weight, and 
glycated hemoglobin level 7.0% to 10.0%.
INTERVENTIONS: Once-daily, subcutaneous liraglutide (3.0 mg) (n = 423), 
liraglutide (1.8 mg) (n = 211), or placebo (n = 212), all as adjunct to 500 
kcal/d dietary deficit and increased physical activity (≥150 min/wk).
MAIN OUTCOMES AND MEASURES: Three coprimary end points: relative change in 
weight, proportion of participants losing 5% or more, or more than 10%, of 
baseline weight at week 56.
RESULTS: Baseline weight was 105.7 kg with liraglutide (3.0-mg dose), 105.8 kg 
with liraglutide (1.8-mg dose), and 106.5 kg with placebo. Weight loss was 6.0% 
(6.4 kg) with liraglutide (3.0-mg dose), 4.7% (5.0 kg) with liraglutide (1.8-mg 
dose), and 2.0% (2.2 kg) with placebo (estimated difference for liraglutide [3.0 
mg] vs placebo, -4.00% [95% CI, -5.10% to -2.90%]; liraglutide [1.8 mg] vs 
placebo, -2.71% [95% CI, -4.00% to -1.42%]; P < .001 for both). Weight loss of 
5% or greater occurred in 54.3% with liraglutide (3.0 mg) and 40.4% with 
liraglutide (1.8 mg) vs 21.4% with placebo (estimated difference for liraglutide 
[3.0 mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8 mg] vs 
placebo, 19.0% [95% CI, 9.1% to 28.8%]; P < .001 for both). Weight loss greater 
than 10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide 
(1.8 mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs 
placebo, 18.5% [95% CI, 12.7% to 24.4%], P < .001; for liraglutide [1.8 mg] vs 
placebo, 9.3% [95% CI, 2.7% to 15.8%], P = .006). More gastrointestinal 
disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and 
placebo. No pancreatitis was reported.
CONCLUSIONS AND RELEVANCE: Among overweight and obese participants with type 2 
diabetes, use of subcutaneous liraglutide (3.0 mg) daily, compared with placebo, 
resulted in weight loss over 56 weeks. Further studies are needed to evaluate 
longer-term efficacy and safety.
TRIAL REGISTRATION: clinicaltrials.gov Identifier:NCT01272232.