Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621017
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Parallel-Group Study Evaluating the Efficacy Safety and Pharmacokinetics of Daily Administrations of the GLP-1 Analogue ROSE-010 on Appetite and Food Intake in Overweight and Obese Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity
The secondary objectives of this study are the following
To assess the efficacy of ROSE-010 on hunger
To assess the efficacy of ROSE-010 on satiety
To assess the efficacy of ROSE-010 on prospective consumption
To assess the efficacy of ROSE-010 on desire to eat
To assess the efficacy of ROSE-010 on palatability
To characterize the pharmacokinetics PK of ROSE-010 following subcutaneous SC administration on Day 1 and Day 7 and
To evaluate safety and tolerability of SC administrations of ROSE-010 to overweight and obese subjects
The secondary objectives of this study are the following
To assess the efficacy of ROSE-010 on hunger
To assess the efficacy of ROSE-010 on satiety
To assess the efficacy of ROSE-010 on prospective consumption
To assess the efficacy of ROSE-010 on desire to eat
To assess the efficacy of ROSE-010 on palatability
To characterize the pharmacokinetics PK of ROSE-010 following subcutaneous SC administration on Day 1 and Day 7 and
To evaluate safety and tolerability of SC administrations of ROSE-010 to overweight and obese subjects
Detailed Description:
This is a randomized placebo-controlled double-blind parallel-group Phase 2 study evaluating the efficacy safety and PK of daily administrations of the GLP-1 analogue ROSE-010 on appetite and food intake in overweight and obese female subjects The study is planned to include 3 parallel groups as follows
Group 1 99 mcg ROSE-010 15 subjects administered SC once daily for 7 consecutive days
Group 2 150 mcg ROSE-010 15 subjects administered SC once daily for 7 consecutive days
Group 3 Placebo 10 subjects administered SC once daily for 7 consecutive days
On Day 1 subjects will be randomized to receive ROSE-010 or placebo Study drug will be administered SC once daily 30 minutes before lunch for 7 consecutive days Days 1 to 7 Assessments of hunger satiety prospective consumption desire to eat palatability and nausea will be performed Blood samples will be collected to evaluate PK
Group 1 99 mcg ROSE-010 15 subjects administered SC once daily for 7 consecutive days
Group 2 150 mcg ROSE-010 15 subjects administered SC once daily for 7 consecutive days
Group 3 Placebo 10 subjects administered SC once daily for 7 consecutive days
On Day 1 subjects will be randomized to receive ROSE-010 or placebo Study drug will be administered SC once daily 30 minutes before lunch for 7 consecutive days Days 1 to 7 Assessments of hunger satiety prospective consumption desire to eat palatability and nausea will be performed Blood samples will be collected to evaluate PK
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