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Clinical Trial 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).


Clinical Trial Description

Subjects with post-bariatric hypoglycemia will be screened for participation in this trial. Eligible patients will complete the rest of the Core phase by entering a run-in period of 4 weeks without any treatment. At the end of the run-in period, participants will be randomized to receive in a blinded manner either pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg or Placebo subcutaneously three times a day (prior to each meal). Participants will blindly self-administer their treatment for a total of 12 weeks when the primary endpoint will be assessed. All participants completing the core phase will be offered to enter the extension phase. Participants will openly self-administer pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg subcutaneously three times a day for a total of 36 weeks of treatment. There will be no more placebo during this extension phase of treatment. Dose changes/adjustments will be possible only during the extension phase and the decision to change the dose of pasireotide will be left to the investigator's judgment. All participants will come for a safety visit after discontinuation or completion of treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05928390
Study type Interventional
Source RECORDATI GROUP
Contact Arnd H MUELLER, MD
Phone +41 79 857 3664
Email mueller.ar@recordati.com
Status Recruiting
Phase Phase 2
Start date January 4, 2024
Completion date April 2026

See also
  Status Clinical Trial Phase
Completed NCT03255629 - Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia Phase 1/Phase 2
Recruiting NCT04615546 - Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia N/A
Completed NCT05560789 - The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia N/A