Short bowel syndrome (SBS), also known as short gut, is a malabsorption disorder caused by a malfunctioning small intestine. The disease leads to diarrhea, dehydration, and malnutrition. Glepaglutide is a novel long-acting glucagon-like peptide-2 (GLP-2) which promotes optimal intestine adaptation. The objective of this study is to assess the efficacy of glepaglutide in patients with short bowel syndrome.
This is a double-blind, single-center, randomized, crossover phase-2 trial that included a total of 22 patients with short bowel syndrome with a fecal wet weight output of 1,500 g/day or more. The participants were randomly assigned to receive the glepaglutide doses of 10 mg-1mg, 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. The primary outcome was the change of fecal wet weight from baseline.
Out of 22 patients, 16 completed the trial. The treatment with 1 mg and 10 mg glepaglutide was associated with an adjusted mean fecal output of -592 g/day and -833 g/day, respectively. Common treatment-related adverse events included stoma complications, peripheral edema, nausea, and injection site reactions.
The research concluded that glepaglutide was well-tolerated and had improved intestinal absorption in patients with short bowel syndrome.