Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517797
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
One-Year Study of S1B-509 vs Placebo for Weight Loss
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IIb Placebo-Controlled Double-Blind Randomized Parallel Groups Study to Determine the Efficacy and Safety of S1B-509 for Weight Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to test whether S1B-509 given orally daily helps people with overweight or obesity to lose more weight than with placebo over a year
Detailed Description:
This trial is to determine proof of concept for S1B-509 vs placebo and to define a suitable dose escalation scheme and range for S1B-509 regarding safety tolerability and efficacy The treatments will be given along with dietary advice and food intake monitoring Change in body weight and in measures relating to obesity and its complications such as diabetes will be measured from baseline to week 48 Safety will be determined from adverse event reports vital signs routine laboratory tests and mental health screeners
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None