Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532578
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Multicenter Trial to Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Status:
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:
The study is designed to evaluate the preliminary efficacy safety population PK profile and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus
Detailed Description:
240 subjects who meet the eligibility criteria will be randomized to 5 cohorts in a 23322 ratio CPX101 120mg Q2W CPX101 160mg Q4W CPX101 160mg Q2W CPX101 240mg Q4W CPX101 240mg Q2WParticipants in each cohort will be randomized in a 31 ratio to receive either CPX101 or placebo The study consists of a 3-week screening period a 24-week treatment period and a 12-week safety follow-up periodDose-titration will be adopted within each cohort to improve GI tolerability
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