Current SBS treatments focus on symptom management, but Glepaglutide offers a long-acting, effective approach to help patients
Medically reviewed by Dr. Shani Saks on Feb. 21, 2025
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Glepaglutide significantly reduced parenteral support (PS) requirements and improved patient-reported outcomes in patients with short bowel syndrome (SBS) and chronic intestinal failure (IF). The treatment also led to notable increases in citrulline concentrations, indicating potential intestinal health benefits, with a safety profile consistent with glucagon-like peptide (GLP)-2 class effects.
Key Findings:
Introduction: Many Short Bowel Syndrome Patients Depend on Parenteral Support, Requiring Novel, Long-Acting Therapies to Improve Outcomes
Short bowel syndrome (SBS) is a condition characterized by a reduced absorptive capacity of the intestine due to extensive bowel resection or congenital conditions. This leads to malabsorption, resulting in dehydration, malnutrition, and weight loss. SBS is highly heterogeneous, with some patients requiring PS to maintain vital functions, while others may compensate via hyperphagia. PS dependency, although life-sustaining, can cause severe complications, including sepsis and liver disease.
Current treatments focus on managing diarrhea with gastrointestinal drugs, but these do not address the underlying disease mechanisms. Recent research has highlighted the role of gut hormones, particularly GLP-2, in enhancing intestinal function and structure; however, GLP-2 has a short half-life of 5 to 7 minutes. Teduglutide, a GLP-2 analog with a half-life of 2 hours, has shown promise, but treatment with teduglutide is time-consuming due to the requirement for daily drug product reconstitution and dosing.
A study published in the journal Gastroenterology investigates glepaglutide, a long-acting GLP-2 analog, exploring its efficacy in reducing PS dependence in SBS patients, with a focus on improving patient outcomes and reducing treatment burden.
Materials and Methodology: Randomized Control Trial
This multinational, placebo-controlled, randomized, parallel-group, double-blind phase 3 trial aimed to evaluate the efficacy of glepaglutide 10 mg once weekly (OW) and twice weekly (TW) subcutaneous injections in stable patients with SBS and chronic IF. Conducted at 29 hospital centers across the US, UK, and other countries, the trial involved patients aged 18–90 years of age who required PS at least three times a week. Participants were randomized to receive either glepaglutide or placebo for 24 weeks.
Results:
A total of 154 patients were screened, with 141 enrolled in the optimization phase. Between October 2018 and July 2022, 106 patients were randomized (35 in each glepaglutide group, 36 in the placebo group). Of these, 89% in the glepaglutide TW group, 97% in the glepaglutide OW group, and all placebo patients completed the 24-week treatment. Baseline characteristics were similar across groups, with an average age of 55.0 (12.4) years. The mean weekly PS volume requirement at baseline was 14.4 (7.8) L/week across 5.9 (1.5) days.
Adverse events, particularly mild injection site reactions, were more frequent in the glepaglutide groups. Severe adverse events were reported in 28.6% of glepaglutide TW patients, 11.4% of OW patients, and 5.6% of placebo patients. Serious adverse events (SAEs) were generally related to underlying conditions, with 25.7% of patients in the glepaglutide groups experiencing SAEs compared to 19.4% in the placebo group.
Conclusion: Glepaglutide 10 MG TW for 24 Weeks Significantly Reduced or Eliminated the Need for Parenteral Support in SBS
Glepaglutide 10 mg TW for 24 weeks effectively reduced or eliminated the need for PS in patients with SBS and chronic IF. It significantly improved patient-reported outcomes compared to placebo. Glepaglutide was generally safe and well-tolerated, with a safety profile consistent with GLP-2 class effects. Long-term efficacy and safety are being explored in ongoing extension trials.
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