Clinical nutrition ESPEN · 2025
Outcomes of glepaglutide on intestinal absorption and parenteral support in patients with short bowel syndrome.
СтатьяКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
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Pinar Ismail, Nielsen Thor Schütt Svane, Soldbro Lise, Hvistendahl Mark Krogh, Berner-Hansen Mark, Jeppesen Palle Bekker
Аннотация
BACKGROUND & AIMS: Glepaglutide, a long-acting glucagon-like peptide 2 (GLP-2) analog, is under development for the treatment of patients with short bowel syndrome (SBS). GLP-2 enhances intestinal adaptation and absorption. This study assessed glepaglutide in terms of its 24-week efficacy on intestinal wet weight and energy absorption, as well as its impact on reducing parenteral support (PS) and maintaining body composition at week 52 in patients with SBS.
METHODS: In this single-center, open-label, phase 3b study, 10 patients with SBS - 8 with intestinal failure (SBS-IF) and 2 with intestinal insufficiency - received glepaglutide 10 mg once weekly via subcutaneous injection. Intestinal absorption was assessed by the gold-standard metabolic balance studies. The primary endpoint was absolute change in intestinal wet weight absorption, while secondary endpoints assessed changes in energy, electrolyte, and macronutrient absorption after 24 weeks of treatment. Additional endpoints included changes in PS use, body composition and safety after 52 weeks of treatment.
RESULTS: At week 24, mean numerical increase in intestinal wet weight absorption was 398 g/day (P = 0.0585) and mean energy absorption 1038 kJ/day (P = 0.0215). Improvements occurred in electrolyte and macronutrient absorption. At week 52, mean PS volume was reduced by 800 mL/day (P = 0.0106) with a reduction in mean PS energy content of 866 kJ/day (P = 0.0103). Body composition and weight remained stable, and glepaglutide demonstrated a manageable safety profile.
CONCLUSION: Patients with SBS treated with glepaglutide demonstrated increased intestinal wet weight and energy absorption, allowing corresponding reductions in PS requirements in those with SBS-IF. Glepaglutide demonstrated a favorable safety profile, positioning it as a promising treatment for patients with SBS.
CLINICALTRIALS: gov no: NCT04991311; ClinicalTrialsRegister.eu EudraCT no: 2020-005194-27.
METHODS: In this single-center, open-label, phase 3b study, 10 patients with SBS - 8 with intestinal failure (SBS-IF) and 2 with intestinal insufficiency - received glepaglutide 10 mg once weekly via subcutaneous injection. Intestinal absorption was assessed by the gold-standard metabolic balance studies. The primary endpoint was absolute change in intestinal wet weight absorption, while secondary endpoints assessed changes in energy, electrolyte, and macronutrient absorption after 24 weeks of treatment. Additional endpoints included changes in PS use, body composition and safety after 52 weeks of treatment.
RESULTS: At week 24, mean numerical increase in intestinal wet weight absorption was 398 g/day (P = 0.0585) and mean energy absorption 1038 kJ/day (P = 0.0215). Improvements occurred in electrolyte and macronutrient absorption. At week 52, mean PS volume was reduced by 800 mL/day (P = 0.0106) with a reduction in mean PS energy content of 866 kJ/day (P = 0.0103). Body composition and weight remained stable, and glepaglutide demonstrated a manageable safety profile.
CONCLUSION: Patients with SBS treated with glepaglutide demonstrated increased intestinal wet weight and energy absorption, allowing corresponding reductions in PS requirements in those with SBS-IF. Glepaglutide demonstrated a favorable safety profile, positioning it as a promising treatment for patients with SBS.
CLINICALTRIALS: gov no: NCT04991311; ClinicalTrialsRegister.eu EudraCT no: 2020-005194-27.