Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595238
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIb Randomised Double-blind Placebo-controlled Study to Evaluate the Efficacy Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity
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:
APRICUS
Brief Summary:
A Phase IIb Randomised Double-blind Placebo-controlled Study to Evaluate the Efficacy Safety and Tolerability of AZD6234 compared with placebo given once a week as subcutaneous injection for 32 weeks in male and female participants of at least 18 years of age who are living with obesity body mass index BMI 30 kgm2 or BMI 27 kgm2 or overweight and at least one weight-related comorbidity
Detailed Description:
The study will comprise of
A screening period of maximum 28 days
A treatment period of 32 weeks
A follow up period after last dose of study drug
This study will consist of 4 cohorts Approximately 231 eligible participants will be randomized to AZD6234 or placebo
A screening period of maximum 28 days
A treatment period of 32 weeks
A follow up period after last dose of study drug
This study will consist of 4 cohorts Approximately 231 eligible participants will be randomized to AZD6234 or placebo
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