Trial results for a Phase 4 study (NCT05038878) investigating elagolix for mild autonomous cortisol excess (MACE) due to adrenal adenomas in postmenopausal women were posted on ClinicalTrials.gov on 2025-03-18. The study, which was terminated, enrolled only 4 participants.
Background
Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist. The study aimed to investigate its potential role in treating mild autonomous cortisol excess (MACE) due to adrenal adenomas in postmenopausal women. MACE is characterized by mildly elevated cortisol levels, often associated with non-cancerous growths in the adrenal glands.
Trial design
The study (NCT05038878) was a Phase 4 trial investigating elagolix in postmenopausal women with mild autonomous cortisol excess (MACE) due to adrenal adenomas. It was designed to assess if elagolix could improve various metabolic and quality of life parameters. The trial enrolled 4 participants and was ultimately terminated.
Key results
Key results were reported for the small cohort of 4 participants. For the outcome of "Number of Participants With Change in Cortisol Level," 2 participants showed a change. Median changes in cortisol level were reported as 0.252 ng/mL, 0.092 ng/mL, 0.092 ng/mL, and 0.4355 ng/mL across different measurements, each with a full range dispersion. Regarding 24-hour urine free cortisol, 1 participant showed a change, with median levels reported as 14 ug/24 hour and 23 ug/24 hour. For the outcome of "Number of Participants With Change in Adenoma Size as Compared to Baseline," 0 participants showed a change. Mean changes in adenoma size were reported as 1.78 cm (Standard Deviation: 0.26), 1.8 cm (Standard Deviation: 0.22), and 2.33 cm (Standard Deviation: 1.27).
What this means
The termination of this Phase 4 trial and its very limited enrollment of 4 participants mean that the reported results are highly preliminary. No definitive conclusions can be drawn regarding the efficacy or safety of elagolix for treating mild autonomous cortisol excess due to adrenal adenomas based on this dataset. The data provides only a snapshot of changes in a few individuals and does not support broad clinical implications.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT05038878, titled "An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women," were posted on 2025-03-18 on clinicaltrials.gov.