Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515418
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over STRIDES
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:
STRIDES
Brief Summary:
This study aims to find out how well a combination of oral azelaprag taken once a day QD or twice a day BID along with a weekly injection of tirzepatide works for weight management in adults 55 years and older The researchers are also looking at safety
Estimated Study Length
with the optional prescreening the study duration may be up to 48 weeks
the treatment duration will be 24 weeks followed by 12 weeks follow-up
the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter
Estimated Study Length
with the optional prescreening the study duration may be up to 48 weeks
the treatment duration will be 24 weeks followed by 12 weeks follow-up
the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter
Detailed Description:
Clinical trial BGE-105-005 will determine if the addition of oral azelaprag to tirzepatide treatment will amplify overall weight loss in participants with obesity aged 55 years and older BGE-105-005 is a randomized double-blind placebo-controlled parallel-arm multi-center study in approximately 220 adults 55 years old with body mass index BMI between 30 and 40 kgm2 inclusive at the time of screening Participants will be randomly assigned to 1 of the 4 study arms A-tirzepatide monotherapy B-azelaprag 300 mg QD plus tirzepatide C-azelaprag 300 mg BID plus tirzepatide D-azelaprag 300 mg BID monotherapy The primary endpoint will be the effect on body weight reduction as measured by mean percent change in body weight at 24 weeks in participants that received azelaprag plus tirzepatide versus tirzepatide alone The study is intended to gather safety and efficacy data in the defined participant population
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