drugset / Trial / NCT05928390

Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

NCT05928390

Phase 2 Active not recruiting 93 enrolled RECORDATI GROUP
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods * 19 weeks for the Core Phase. It is composed of: * a Screening period: a maximum of 3 weeks * a Run-in period (no treatment): 4 weeks * a Blinded Treatment Phase: 12 weeks * 36 weeks Extension Phase = an open-label Treatment period * 4 weeks for the safety follow-up period (without any treatment).

Timeline

Start
2024-01-04
Primary completion
2026-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Pasireotide Other / unclassified 50 ug Subcutaneous
Subject Pasireotide Other / unclassified 100 ug Subcutaneous
Subject Pasireotide Other / unclassified 200 ug Subcutaneous