Gastroenterology · 2024
Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Jeppesen Palle B, Vanuytsel Tim, Subramanian Sukanya, Joly Francisca, Wanten Geert, Lamprecht Georg, Kunecki Marek, Rahman Farooq, Nielsen Thor S S, Berner-Hansen Mark, Pape Ulrich-Frank, Mercer David F
Аннотация
BACKGROUND & AIMS: Glepaglutide is a long-acting glucagon-like peptide (GLP)-2 analogue developed to improve intestinal absorption in patients with short bowel syndrome (SBS). The authors conducted a trial to establish the efficacy and safety of glepaglutide in reducing parenteral support (PS) needs in patients with SBS with intestinal failure.
METHODS: In an international, placebo-controlled, randomized, parallel-group, double-blind, phase 3 trial, patients with SBS with intestinal failure requiring PS ≥3 d/wk were randomized 1:1:1 to 24 weeks of glepaglutide 10 mg twice weekly or once weekly or placebo. PS volume was equivalently reduced if mean urine volume of a 48-hour balance period exceeded baseline values by >10%.
RESULTS: One hundred six patients were randomized and dosed. Glepaglutide twice weekly significantly reduced weekly PS volumes from baseline to week 24 vs placebo (mean change, -5.13 vs -2.85 L/wk; P = .0039; primary end point). Results were similar across major anatomic subgroups. Glepaglutide twice weekly was also superior to placebo for key secondary end points of proportion of patients achieving clinical response, defined as ≥20% PS volume reduction from baseline to weeks 20 and 24 (65.7% vs 38.9%; P = .0243) and patients achieving a reduction in days on PS ≥1 d/wk from baseline to week 24 (51.4% vs 19.4%; P = .0043). Complete PS weaning ("enteral autonomy") was achieved for 5 patients (14%) receiving glepaglutide twice weekly vs 0 for patients receiving placebo. No statistically significant differences were found for glepaglutide once weekly vs placebo for primary or key secondary end points. Significant glepaglutide benefits on patient-reported outcome (Patient Global Impression of Change) were found. Glepaglutide was assessed to be safe and well tolerated.
CONCLUSIONS: Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was well tolerated. (ClinicalTrials.gov, Number: NCT03690206; ClinicalTrialsRegister.eu, Number: 2017-004394-14.).
METHODS: In an international, placebo-controlled, randomized, parallel-group, double-blind, phase 3 trial, patients with SBS with intestinal failure requiring PS ≥3 d/wk were randomized 1:1:1 to 24 weeks of glepaglutide 10 mg twice weekly or once weekly or placebo. PS volume was equivalently reduced if mean urine volume of a 48-hour balance period exceeded baseline values by >10%.
RESULTS: One hundred six patients were randomized and dosed. Glepaglutide twice weekly significantly reduced weekly PS volumes from baseline to week 24 vs placebo (mean change, -5.13 vs -2.85 L/wk; P = .0039; primary end point). Results were similar across major anatomic subgroups. Glepaglutide twice weekly was also superior to placebo for key secondary end points of proportion of patients achieving clinical response, defined as ≥20% PS volume reduction from baseline to weeks 20 and 24 (65.7% vs 38.9%; P = .0243) and patients achieving a reduction in days on PS ≥1 d/wk from baseline to week 24 (51.4% vs 19.4%; P = .0043). Complete PS weaning ("enteral autonomy") was achieved for 5 patients (14%) receiving glepaglutide twice weekly vs 0 for patients receiving placebo. No statistically significant differences were found for glepaglutide once weekly vs placebo for primary or key secondary end points. Significant glepaglutide benefits on patient-reported outcome (Patient Global Impression of Change) were found. Glepaglutide was assessed to be safe and well tolerated.
CONCLUSIONS: Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was well tolerated. (ClinicalTrials.gov, Number: NCT03690206; ClinicalTrialsRegister.eu, Number: 2017-004394-14.).