Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

Summary

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Timeline

Start

2018-10-04

Primary completion

2022-07-26

Completion

2022-07-26

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Glepaglutide SC Injections Twice Weekly vs Placebo SC Injections Twice Weekly; p = 0.0039; Difference to Placebo -2.28 (95% CI -3.83 to -0.73) reads as mixed primary results NCT03690206 ↗

registry Glepaglutide SC Injections Once Weekly and Placebo Once Weekly vs Placebo SC Injections Twice Weekly; p = 0.2700; Difference to Placebo -0.91 (95% CI -2.52 to 0.71) reads as mixed primary results NCT03690206 ↗

release “Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a statistically significant reduction in weekly parenteral support volume by 5.13 Liters/week” reads as met primary endpoint zealandpharma.com ↗

Publications

• Jeppesen PB, Vanuytsel T, Subramanian S, Joly F, Wanten G, Lamprecht G, Kunecki M, Rahman F, Nielsen TSS, Berner-Hansen M, Pape UF, Mercer DF. Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial. Gastroenterology. 2025 Apr;168(4):701-713.e6. doi: 10.1053/j.gastro.2024.11.023. Epub 2024 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glepaglutide	Peptide	10 mg	Subcutaneous

Indications