NCT05928390

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

A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Post-Bariatric Hypoglycemia

Interventions

Type	Name	Description
DRUG	Pasireotide Diaspartate	Injectable ampoules

Timeline

• Start date: 2024-01-04
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-07-03
• Last updated: 2025-09-22

Locations

29 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study