In this study, the first four weeks were used to maintain the hydrocortisone dose and to see if there would be a difference in androstenedione dose. So both groups of patients received the same amount of hydrocortisone that they started, but they had follow up labs with the androstenedione. After four weeks, it was noted that there was a decrease in androstenedione levels in the group that received crinecerfont.

Following the four week point, the goal then was to see if we could decrease the amount of hydrocortisone given while maintaining androstenedione levels. At the end of 28 weeks, we found that the group that received crinecerfont had lower hydrocortisone doses compared to those who received the placebo. They were also in the crinecerfont group, able to maintain their androstenedione levels.

This is very important because by giving lower levels of hydrocortisone, we can minimize the side effects and maximize growth. At 28 weeks, the dose in hydrocortisone was decreased to 12.8mg/m in the crinecerfont group, versus the 17mg/m in the placebo group. In addition, those who received the crinecerfont had decreases in their BMI versus a slight increase in BMI in the placebo group and had improved insulin resistance.