Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia
Primary result · Change in glucocorticoid dose (with androstenedione control)Result — go to the resultLeast-squares mean difference −17.0 percentage pointsAuthors' conclusion
Among patients with CAH, the use of crinecerfont resulted in a greater decrease from baseline in the mean daily glucocorticoid dose, including a reduction to the physiologic range, than placebo following evaluation of adrenal androgen levels.
Study context
- Population
- Adults with classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH); mean baseline glucocorticoid dose 17.6 mg/m² BSA/day hydrocortisone equivalents; mean androstenedione 620 ng/dLrandomized 2:1
- Participants
- 182 adults
- Comparison
- Crinecerfont vs placebo for 24 weeks
- Crinecerfontn = 122
- Placebon = 60reference
- Primary endpoint
- Percent change in daily glucocorticoid dose from baseline with maintenance of androstenedione control
- Follow-up
- Week 24
Methodological detailsphase 3, placebo-controlled, 176 patients (97%) remained in the trial at week 24
- Phase 3
- Placebo-controlled
- 176 patients (97%) remained in the trial at week 24
Primary result
As reported in the abstract
Change in glucocorticoid dose (with androstenedione control)
Least-squares mean difference
−17.0 percentage points
P < 0.001
Change by group
Crinecerfont
−27.3%
Placebo
−10.3%
Further findings
Physiologic glucocorticoid dose (with androstenedione control) · week 24
P < 0.001
Ng per deciliter
| Outcome | Crinecerfont | Placebo | Least-squares mean difference (ng per deciliter) | P value |
|---|---|---|---|---|
| Change in androstenedione level · week 4 | −299 | 45.5 | −345 | P < 0.001 |
Safety
- Fatigue and headache were the most common adverse events in both groups
Original publication
Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia. N Engl J Med. Published 1 June 2024. doi:10.
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