Clinical trial • Phase III • Endocrinology
semaglutide for Obesity
Phase III trial of semaglutide for Obesity. BI 456906 compared with semaglutide (dose and schedule not specified)-controlled. 30 participants.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Other
Key dates
- Initial CTIS Submission Date
- 02-10-2024
- First CTIS Authorization Date
- 28-10-2024
Trial design
BI 456906 compared with semaglutide (dose and schedule not specified)-controlled Phase III trial across 1 site in Netherlands.
- Comparator
- BI 456906 compared with semaglutide (dose and schedule not specified)
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable populations not selected; trial includes healthy volunteers; no description of consent or assent handling available in source..
- Vulnerable Population
- Vulnerable populations not selected; trial includes healthy volunteers; no description of consent or assent handling available in source.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 40
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 400
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Academisch Medisch Centrum
- Department Name
- #NDL1 Pharmacy
- Contact Person Name
- Victor Gerdes
- Contact Person Email
- v.e.gerdes@amsterdamumc.nl
- Number Of Participants
- 30
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 456906
- Modality
- Other
- Investigational Product Name
- semaglutide
- Active Substance
- semaglutide
- Modality
- Peptide/protein/enzyme
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