Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).

Phase 2 Completed 17 enrolled Alfasigma S.p.A.

RandomizedCrossoverTriple-blindTreatment

Summary

This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.

Timeline

Start: 2021-12-15
Primary completion: 2023-04-12
Completion: 2023-04-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Modified Full Analysis Set 1 Velusetrag vs Modified Full Analysis Set 1 Placebo; p =0.1279; Median Difference (Net) -0.239 (95% CI -0.553 to 0.074); paired T-test NCT05724069 ↗

paper Velusetrag treatment was associated with improved symptoms versus placebo, although differences were not statistically significant at this sample size. PMID 41553253 ↗

Publications

Malagelada C, De Giorgio R, Cogliandro RF, Alcala-Gonzalez L, Costanzini A, Scuderi V, Manzoni S, Pasquali E, Tack J, Stanghellini V. Clinical Trial: Efficacy and Safety of Velusetrag in Chronic Intestinal Pseudo-Obstruction: A Randomized, Phase 2, Placebo-Controlled, Crossover, Multiple (n = 1), Proof-of-Concept Study. Neurogastroenterol Motil. 2026 Jan;38(1):e70246. doi: 10.1111/nmo.70246.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Velusetrag	Small molecule	15 mg	Oral