About the CAPTAIN-T2D Study
The CAPTAIN-T2D Study is evaluating an investigational medication to see if it is safe and effective in managing T2D in adults with elevated cortisol levels. Cortisol is a hormone that can affect blood sugar and overall health, and it may make it harder to manage T2D.
There will be a screening period lasting up to 9 weeks. During this time, potential participants will complete general health checks, including taking a prescription medication to see if their cortisol levels are elevated. These assessments help decide if they can move on to the next part of the study. Only a portion of those screened (about 20%) will qualify to continue to the study treatment period.
Participants who are enrolled in the study treatment period will be randomly assigned to receive either the investigational medication or placebo (a substance that looks like the investigational medication but has no active ingredients). There's an up to 25% chance of receiving placebo. All study medications will be in tablet form and taken orally (by mouth) once daily for about 24 weeks.
The total study duration is about 37 weeks (about 9 months), including a 4-week follow-up period. The study involves up to 12 in-person and phone visits, as well as some at-home assessments, where participants will receive ongoing health monitoring and support.