Clinical trial • Phase III • Endocrinology
Pasireotide for Post-bariatric hypoglycaemia|Postprandial hypoglycaemia|Hyperinsulinaemic hypoglycaemia
Phase III trial of Pasireotide for Post-bariatric hypoglycaemia|Postprandial hypoglycaemia|Hyperinsulinaemic hypoglycaemia. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Post-bariatric hypoglycaemia|Postprandial hypoglycaemia|Hyperinsulinaemic hypoglycaemia
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 17-12-2025
- First CTIS Authorization Date
- 23-02-2026
Trial design
None/Not specified-controlled Phase III trial across 1 site in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population not selected; no consent/assent details provided..
- Vulnerable Population
- Vulnerable population not selected; no consent/assent details provided.
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 3
- Consent Approach
- Not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 40
Germany
- Earliest CTIS Part Ii Submission Date
- 09-02-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Nuvisan GmbH
- Department Name
- Clinical Services
- Contact Person Name
- Dennis Regul
- Contact Person Email
- dennis.regul@nuvisan.com
- Number Of Participants
- 40
Sponsor
Primary sponsor
- Full Name
- Recordati AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Pasireotide
- Active Substance
- Pasireotide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Frequency
- Single-dose
Related trials
Other published trials that may interest you.