Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: A randomised phase 2 trial
The Lancet: Gastroenterology & Hepatology Mar 21, 2019
Naimi RM, et al. - In patients with short bowel syndrome, researchers evaluated the therapeutic potential of glepaglutide, a novel long-acting glucagon-like peptide-2 (GLP-2) analogue, for reducing faecal output and increasing intestinal absorption. For this investigation, they randomly assigned adults (aged ≥18 to ≤90 years) with short bowel syndrome and with a faecal wet weight output of 1500 g/day or more to receive one of six dose sequences of glepaglutide (10 mg, 1 mg; 10 mg, 0·1 mg; 1 mg, 10 mg; 1 mg, 0·1 mg; 0·1 mg, 10 mg; or 0·1 mg, 1 mg). Stoma complications, injection site reactions, peripheral oedema, nausea and abdominal pain, polyuria and fatigue, abdominal distention, vomiting, and dizziness and cough and decreased appetite were common treatment-related adverse events. Abdominal pain, stoma obstruction, catheter-related sepsis, and infection of unknown origin were related or possibly related serious adverse events. The results obtained from this single-centre, double-blind, crossover, randomised phase 2 trial indicate that glepaglutide was well tolerated and in patients with short intestinal syndrome with 1 mg and 10 mg glepaglutide, but not 0·1 mg glepaglutide, it was linked to improved intestinal absorption. Larger phase 3 longer-term clinical trials were initiated to fully evaluate the safety and effectiveness of glepaglutide. During the trial, no patients died.
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