Trial results for baxdrostat were posted on ClinicalTrials.gov on 2025-12-17, showing no incidence of abnormal stimulated cortisol response at Week 8 in participants with uncontrolled hypertension. This Phase 2 study evaluated cortisol reserve following treatment with baxdrostat compared to placebo.
Background
Baxdrostat is an investigational drug being studied for conditions such as uncontrolled hypertension. This particular study focused on evaluating the cortisol reserve in response to an adrenocorticotropic hormone (ACTH) stimulation test, which is an important safety consideration for drugs that may affect adrenal function.
Trial design
The study (NCT06336356) was a Phase 2 trial with an overall status of COMPLETED. It enrolled 48 participants diagnosed with uncontrolled hypertension. The trial's main purpose was to assess the serum free cortisol response after an ACTH stimulation test at baseline and at Week 8. Participants received either baxdrostat or placebo.
Key results
The key results from the study focused on the incidence of abnormal stimulated cortisol and the occurrence of adverse events. For the outcome 'Incidence of Abnormal Stimulated Cortisol at Week 8':
- In the baxdrostat 2 mg group, 0 participants experienced an abnormal stimulated cortisol response.
- In the placebo group, 0 participants experienced an abnormal stimulated cortisol response.
This outcome was assessed in 26 participants in the baxdrostat 2 mg group and 15 participants in the placebo group.
Regarding 'Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)':
- 10 participants in the baxdrostat 2 mg group reported adverse events, compared to 6 participants in the placebo group.
Further measurements for this outcome reported 0 participants in both the baxdrostat 2 mg and placebo groups for certain categories. Additionally, 1 participant in the baxdrostat 2 mg group and 0 participants in the placebo group were reported for another specific measurement of adverse events.
What this means
The results indicate that baxdrostat treatment did not lead to an abnormal stimulated cortisol response at Week 8 in participants with uncontrolled hypertension, which is a positive safety finding given the drug's potential mechanism of action. The observed adverse events were numerically higher in the baxdrostat group compared to placebo, with 10 participants versus 6 participants, respectively. However, specific adverse events of special interest were not observed in either group, suggesting a generally manageable safety profile for the measured outcomes in this Phase 2 study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06336356, titled 'A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension,' were posted on 2025-12-17 on clinicaltrials.gov.