Background: Safety and efficacy of liraglutide 3.0 mg, adjunct to 500 kcal/day dietary deficit
and exercise, for weight management, was investigated.
Methods: Adults (BMI ≥27 kg/m2 with ≥1 comorbidity or ≥30 kg/m2) were randomized 2:1 to once-daily s.c. liraglutide 3.0 mg (n = 2487) or placebo
(n = 1244). Data are observed means for the full analysis set (exposed individuals
with ≥1 post-baseline assessment) with LOCF at week 56, unless stated otherwise. Statistical
analyses are estimated treatment differences (ETD; ANCOVA, continuous variables) or
odds ratios (OR; logistic regression, categorical). Baseline BMI subgroups: ≤29.9,
30 – 34.9, 35 – 39.9, ≥40 kg/m2
. Baseline characteristics: age 45.1 years, 78.5% female, body weight (BW) 106.2 kg,
BMI 38.3 kg/m2, 61.2% with prediabetes.
Results: 92% on liraglutide lost BW vs. 65% on placebo). BW loss ≥5% occurred in 63% (liraglutide)
vs. 27% (placebo; OR 4.8, p < 0.0001). BW loss > 10% and > 15% with liraglutide vs.
placebo was seen in 33% vs. 11% (OR 4.3, p < 0.0001) and 14% vs. 3.5% (OR 4.9, p <
0.0001). Completers on liraglutide (n = 1789, 72%) lost 9.2% (9.7 kg) of BW vs. 3.5%
(3.8 kg) on placebo (n = 801, 64%; ETD -5.7%, p < 0.0001). BW loss with liraglutide
was similar in those with/without prediabetes at screening (-8.0% vs. -7.9%, p = 0.59)
and across baseline BMI subgroups (p = 0.054,%; p = 0.54,kg).
Conclusions: Liraglutide was well tolerated: safety profile was consistent with previous trials;
gastrointestinal disorders were most common. Liraglutide 3.0 mg, induced significant
weight loss compared with placebo, independent of prediabetes status and BMI.
Joachim Kienhöfer meldet einen potenziellen Interessenkonflikt an.
Details liegen bei der Kongressorganisation K.I.T. Group GmbH vor.
