Glepaglutide, a Long-acting Glucagon-like Peptide-2 Analog, Reduces Parenteral Support in Patients with Short Bowel Syndrome: a Phase 3, Randomized, Controlled Trial
Abstract
BACKGROUND AND AIMS
Glepaglutide is a long-acting GLP-2 analog developed to improve intestinal absorption in short bowel syndrome (SBS) patients. We conducted a trial to establish efficacy and safety of glepaglutide in reducing parenteral support (PS) needs in SBS patients with intestinal failure (IF).
METHODS
In an international, placebo-controlled, randomized, parallel-group, double-blind, phase 3 trial, SBS-IF patients requiring PS ≥3 days/week were randomized 1:1:1 to 24 weeks of glepaglutide 10 mg twice-weekly (TW) or once-weekly (OW), or placebo. PS volume was equivalently reduced if average urine volume of a 48-hour balance period exceeded baseline values by >10%.
RESULTS
106 patients were randomized and dosed. Glepaglutide TW significantly reduced weekly PS volumes from baseline to week 24 versus placebo (mean change of -5.13 vs. -2.85 L/week; P = .0039; primary endpoint). Results were similar across major anatomical subgroups. Glepaglutide TW was also superior to placebo for key secondary endpoints 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 day/week 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 TW versus 0 for placebo patients. No statistically significant differences were shown for glepaglutide OW…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 106 participants or records.
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