Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06970405
Status:
WITHDRAWN
Last Update Posted:
2025-09-17
First Post:
2025-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy
Status:
WITHDRAWN
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity.
The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* How much study drug is in the blood at different times
* What effect the study drug has on the blood clotting
* What effect the study drug has on hormone levels
* What effect the study drug has on some organs that produce hormones
* What effect hormones have on the side effects produced by the study drug
* Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* How much study drug is in the blood at different times
* What effect the study drug has on the blood clotting
* What effect the study drug has on hormone levels
* What effect the study drug has on some organs that produce hormones
* What effect hormones have on the side effects produced by the study drug
* Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: