Christina C. Nexøe‐Larsen , MD 1 , Pernille H. Sørensen , MD 1 , Helene Hausner , PhD 2 , Mikkel Agersnap , MD 3 , Mille Baekdal , MD 1 , Andreas Brønden , MD 1 , Lea N. Gustafsson , MSc 4 , David P. Sonne , MD 1 , 5 , Louise Vedtofte , PhD 1 , Tina Vilsbøll , MD 1 , 6 , Filip K. Knop , MD , 1 , 6 , 7
10 July 2018
Treatment with liraglutide 3.0 mg has been associated with gallbladder‐related adverse events. To conduct a single‐centre, double‐blind, 12‐week trial comparing the effect of 0.6 mg liraglutide and steady‐state liraglutide 3.0 mg with placebo on gallbladder emptying in adults with body mass index (BMI) ≥27 kg/m 2 and without diabetes.
Participants were randomized 1:1 to once‐daily subcutaneous liraglutide ( n = 26) or placebo ( n = 26), starting at 0.6 mg with 0.6‐mg weekly increments to 3.0 mg, with nutritional and physical activity counselling. A 600‐kcal (23.7 g fat) liquid meal test was performed at baseline, after the first dose and after 12 weeks. The primary endpoint was the 12‐week maximum postprandial gallbladder ejection fraction (GBEF max), measured over 240 minutes after starting the meal.
Baseline characteristics were similar between groups (mean ± SD overall age 47.6 ± 10.0 years, BMI 32.6 ±3.4 kg/m 2, 50% women). Mean 12‐week GBEF max (treatment difference −3.7%, 95% confidence interval [CI] −13.1, 5.7) and area under the GBEF curve in the first 60 minutes (−390% × min, 95% CI −919, 140) did not differ for liraglutide 3.0 mg ( n = 23) vs placebo ( n = 24). The median (range) time to GBEF max was 151 (11‐240) minutes with liraglutide 3.0 mg and 77 (22‐212) minutes with placebo. Similar findings were noted after the first 0.6‐mg liraglutide dose. Gastrointestinal disorders, notably nausea and constipation, were the most frequently reported adverse events.