drugset / Trial / NCT04964986
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
Timeline
- Start
- 2021-06-14
- Primary completion
- 2023-06-06
- Completion
- 2023-06-06
Outcome
Met primary endpoint
paper At 48 weeks, increases in wet weight absorption by 316 g/day (p = 0.039), energy absorption by 1134 kJ/day (p = 0.041) PMID 39461299 ↗
registry analysis (superiority test); Apraglutide SC Injections, Once Weekly; p = 0.041; paired t-test NCT04964986 ↗
Publications
- Ekhlas D, Verbiest A, Stas M, De Meyere L, Vandermeulen G, Toth J, Geboers K, Timmermans L, Verspecht C, Wauters L, Vermeersch P, Jeppesen PB, Verbeke K, Joly F, Derrien M, Raes J, Vanuytsel T. Early ecological changes in intestinal microbiota with the long-acting GLP-2 analog apraglutide in short bowel syndrome. Clin Nutr ESPEN. 2026 Jun;73:103138. doi: 10.1016/j.clnesp.2026.103138. Epub 2026 Mar 26.
- Verbiest A, Hvistendahl MK, Bolognani F, Li C, Youssef NN, Huh S, Menys A, Bhatnagar G, Vanslembrouck R, Peeters R, Sartoris R, Vermeersch P, Wauters L, Verbeke K, Jeppesen PB, Joly F, Vanuytsel T. Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon-in-continuity: A multicenter, open-label, metabolic balance study. Clin Nutr. 2024 Dec;43(12):158-166. doi: 10.1016/j.clnu.2024.10.011. Epub 2024 Oct 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apraglutide | Peptide | — | Subcutaneous |