drugset / Trial / NCT05928390
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pasireotide | Other / unclassified | 50 ug | Subcutaneous |
| Subject | Pasireotide | Other / unclassified | 100 ug | Subcutaneous |
| Subject | Pasireotide | Other / unclassified | 200 ug | Subcutaneous |