Study summary · research use only
Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This randomised, double-blind, placebo-controlled, dose-finding phase 2 trial (ClinicalTrials.gov NCT04667377) conducted in 43 centres in 12 countries evaluated glucagon receptor-GLP-1 receptor dual agonist survodutide (BI 456906) in human participants with obesity (aged 18-75 years, BMI ≥27 kg/m2, without diabetes) over 46 weeks (20 weeks dose escalation, 26 weeks maintenance). Participants were randomly assigned to subcutaneous survodutide (0.6, 2.4, 3.6, or 4.8 mg) or placebo once weekly; 387 participants were enrolled and 386 were treated. The abstract reports mean bodyweight changes from baseline to week 46 of -6.2% (0.6 mg), -12.5% (2.4 mg), -13.2% (3.6 mg), -14.9% (4.8 mg), and -2.8% (placebo), with bodyweight reduced dose-dependently across tested doses. Adverse events, primarily gastrointestinal, occurred in 91% of survodutide recipients and 75% of placebo recipients.
Abstract
Obesity is a widespread and chronic condition that requires long-term management; research into additional targets to improve treatment outcomes remains a priority. This study aimed to investigate the safety, tolerability, and efficacy of glucagon receptor-GLP-1 receptor dual agonist survodutide (BI 456906) in obesity management. In this randomised, double-blind, placebo-controlled, dose-finding phase 2 trial conducted in 43 centres in 12 countries, we enrolled participants (aged 18-75 years, BMI ≥27 kg/m2, without diabetes) and randomly assigned them by interactive response technology (1:1:1:1:1; stratified by sex) to subcutaneous survodutide (0.6, 2.4, 3.6, or 4.8 mg) or placebo once-weekly for 46 weeks (20 weeks dose escalation; 26 weeks dose maintenance). The primary endpoint was the percentage change in bodyweight from baseline to week 46. Primary analysis included the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of trial medication and who had analysable data for at least one efficacy endpoint) and was based on the dose assigned at randomisation (planned treatment), including all data censored for COVID-19-related discontinuations; the sensitivity analysis was based on the actual dose received during maintenance phase (actual treatment) and included on-treatment data. Safety analysis included all participants who received at least one dose of study drug. The trial is registered with ClinicalTrials.gov (NCT04667377) and EudraCT (2020-002479-37). Between March 30, 2021, and Nov 11, 2021, we enrolled 387 participants; 386 (100%) participants were treated (0.6 mg, n=77; 2.4 mg, n=78; 3.6 mg, n=77; 4.8 mg, n=77; placebo n=77) and 233 (60.4%) of 386 completed the 46-week treatment period (187 [61%] of 309 receiving survodutide; 46 [60%] of 77 receiving placebo). When analysed according to planned treatment, mean (95% CI) changes in bodyweight from baseline to week 46 were -6.2% (-8.3 to -4.1; 0.6 mg); -12.5% (-14.5 to -10.5; 2.4 mg); -13.2% (-15.3 to -11.2; 3.6 mg); -14.9% (-16.9 to -13.0; 4.8 mg); -2.8% (-4.9 to -0.7; placebo). Adverse events occurred in 281 (91%) of 309 survodutide recipients and 58 (75%) of 77 placebo recipients; these were primarily gastrointestinal in 232 (75%) of 309 survodutide recipients and 32 (42%) of 77 placebo recipients. All tested survodutide doses were tolerated, and dose-dependently reduced bodyweight. Boehringer Ingelheim.
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