Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579092
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIb Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity
Status:
RECRUITING
Status Verified Date:
2024-10
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:
VISTA
Brief Summary:
A Phase IIb global randomized parallel-group double-blind placebo-controlled multicenter study to assess the efficacy and safety of AZD5004 compared with placebo given once daily as an oral tablets for 36 weeks in male and female participants at least 18 years of age who are living with obesity body mass index BMI 30 kgm2 or overweight BMI 27 kgm2 who have at least 1 weight-related comorbidity
Detailed Description:
This is a Phase IIb global randomized parallel-group double-blind placebo-controlled multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo given once daily as an oral tablet or tablets for a duration of 36 weeks in adults aged 18 years and above who are living with obesity BMI 30 kgm2 or overweight BMI 27 kgm2 and have at least 1 weight-related comorbidity Hypertension Dyslipidemia or hyperlipidemia CV disease andor Obstructive sleep apnea Approximately 304 participants will be randomized in the study The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss 5 of baseline weight at 26 weeks
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