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Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity.

ABSTRACT: AIMS: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/m2 and without diabetes. METHODS: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 (GBEFmax ), measured over 240?minutes after starting the meal. RESULTS:Baseline characteristics were similar between groups (mean?±?SD overall age 47.6?±?10.0?years, BMI 32.6?±3.4?kg/m2 , 50% women). Mean 12-week GBEFmax (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 GBEFmax 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. CONCLUSIONS:Treatment with liraglutide did not affect the GBEFmax but appeared to prolong the time to GBEFmax .

SUBMITTER: Nexoe-Larsen CC

PROVIDER: S-EPMC6220792 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity.

Nexøe-Larsen Christina C CC Sørensen Pernille H PH Hausner Helene H Agersnap Mikkel M Baekdal Mille M Brønden Andreas A Gustafsson Lea N LN Sonne David P DP Vedtofte Louise L Vilsbøll Tina T Knop Filip K FK

Diabetes, obesity & metabolism 20180710 11

<h4>Aims</h4>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<sup>2</sup> and without diabetes.<h4>Methods</h4>Participants were randomized 1:1 to once-daily subcutaneous liraglutide (n = 26) or placebo (n = 26), starting at 0.6 mg with ...[more]

PMID: 29892986

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Project description:ImportancePhase 3 trials have not compared semaglutide and liraglutide, glucagon-like peptide-1 analogues available for weight management.ObjectiveTo compare the efficacy and adverse event profiles of once-weekly subcutaneous semaglutide, 2.4 mg, vs once-daily subcutaneous liraglutide, 3.0 mg (both with diet and physical activity), in people with overweight or obesity.Design, setting, and participantsRandomized, open-label, 68-week, phase 3b trial conducted at 19 US sites from September 2019 (enrollment: September 11-November 26) to May 2021 (end of follow-up: May 11) in adults with body mass index of 30 or greater or 27 or greater with 1 or more weight-related comorbidities, without diabetes (N = 338).InterventionsParticipants were randomized (3:1:3:1) to receive once-weekly subcutaneous semaglutide, 2.4 mg (16-week escalation; n = 126), or matching placebo, or once-daily subcutaneous liraglutide, 3.0 mg (4-week escalation; n = 127), or matching placebo, plus diet and physical activity. Participants unable to tolerate 2.4 mg of semaglutide could receive 1.7 mg; participants unable to tolerate 3.0 mg of liraglutide discontinued treatment and could restart the 4-week titration. Placebo groups were pooled (n = 85).Main outcomes and measuresThe primary end point was percentage change in body weight, and confirmatory secondary end points were achievement of 10% or more, 15% or more, and 20% or more weight loss, assessed for semaglutide vs liraglutide at week 68. Semaglutide vs liraglutide comparisons were open-label, with active treatment groups double-blinded against matched placebo groups. Comparisons of active treatments vs pooled placebo were supportive secondary end points.ResultsOf 338 randomized participants (mean [SD] age, 49 [13] years; 265 women [78.4%]; mean [SD] body weight, 104.5 [23.8] kg; mean [SD] body mass index, 37.5 [6.8]), 319 (94.4%) completed the trial, and 271 (80.2%) completed treatment. The mean weight change from baseline was -15.8% with semaglutide vs -6.4% with liraglutide (difference, -9.4 percentage points [95% CI, -12.0 to -6.8]; P < .001); weight change with pooled placebo was -1.9%. Participants had significantly greater odds of achieving 10% or more, 15% or more, and 20% or more weight loss with semaglutide vs liraglutide (70.9% of participants vs 25.6% [odds ratio, 6.3 {95% CI, 3.5 to 11.2}], 55.6% vs 12.0% [odds ratio, 7.9 {95% CI, 4.1 to 15.4}], and 38.5% vs 6.0% [odds ratio, 8.2 {95% CI, 3.5 to 19.1}], respectively; all P < .001). Proportions of participants discontinuing treatment for any reason were 13.5% with semaglutide and 27.6% with liraglutide. Gastrointestinal adverse events were reported by 84.1% with semaglutide and 82.7% with liraglutide.Conclusions and relevanceAmong adults with overweight or obesity without diabetes, once-weekly subcutaneous semaglutide compared with once-daily subcutaneous liraglutide, added to counseling for diet and physical activity, resulted in significantly greater weight loss at 68 weeks.Trial registrationClinicalTrials.gov Identifier: NCT04074161.

Dataset Information

Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity.

Publications

Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity.

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