Relacorilant lowers odds for loss of BP control for adults with Cushing’s syndrome
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Key takeaways:
- Adults who had reductions in BP and glucose with relacorilant at 22 weeks and continued the drug for 12 weeks had lower odds for loss of BP control than placebo.
- No changes in safety profile were observed.
A selective cortisol modulator was linked to lower odds for loss of blood pressure control among adults with Cushing’s syndrome compared with placebo, according to topline results from a phase 3 trial.
As Healio previously reported, adults with Cushing’s syndrome who received relacorilant (Corcept Therapeutics) for 22 weeks had reductions in BP and glucose in the open-label portion of the phase 3 GRACE trial. In new results from the randomized, double-blind withdrawal portion of GRACE, adults who continued relacorilant for 12 weeks were more likely to sustain their lower BP than those who switched to placebo.
In the withdrawal portion of the trial, adults who achieved a prespecified improvement for hypertension or hyperglycemia in the open-label portion were randomly assigned, 1:1, to relacorilant or placebo for 12 weeks. Loss of BP control was the primary endpoint of the withdrawal phase of the trial.
At 12 weeks, adults receiving relacorilant were less likely to experience loss of BP control than the placebo group (OR = 0.17; P = .02). Relacorilant was well tolerated, and there were no differences in safety profile between the relacorilant and placebo groups.
“The data from GRACE make a compelling case for the use of relacorilant in patients with endogenous hypercortisolism,” Rosario Pivonello, MD, PhD, professor of endocrinology at Università Federico II di Napoli in Italy and principal investigator of the GRACE study, said in a press release. “That patients experienced clinically significant improvements in hypertension, hyperglycemia and the other signs and symptoms of Cushing’s syndrome, without significant safety burden, is greatly encouraging for physicians and the patients they seek to help.”
Additional data from the GRACE trial will be presented at the ENDO annual meeting June 3 and at the Heart in Diabetes conference June 7. According to the press release, Corcept Therapeutics plans to submit a new drug application to the FDA in the third quarter.
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