Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study
Authors' conclusion
Patients treated with relacorilant were more likely to maintain hypertension control compared with patients treated with placebo. The findings support consideration of relacorilant as a therapeutic option to reduce the harmful and debilitating effects of endogenous hypercortisolism.
Study context
- Population
- Adults aged 18–80 years with endogenous hypercortisolism (Cushing's syndrome) and hypertension, hyperglycaemia, or both, with ≥2 clinical signs or symptoms of hypercortisolism, who met response criteria after the open-label relacorilant phase; 77 centres in 11 countriesrandomised
- Participants
- 62 adults
- Comparison
- Continued relacorilant vs placebo in the randomised-withdrawal phase
- Relacorilantn = 30
- Placebon = 32reference
- Primary endpoint
- Proportion of patients who lost hypertension response during the randomised-withdrawal phase
- Follow-up
- Week 12
Methodological detailsmulticentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal, 22-week open-label relacorilant phase before randomisation
- Multicentre
- Phase 3
- Double-blind
- Placebo-controlled
- Randomised-withdrawal
- 22-week open-label relacorilant phase before randomisation
Primary result
As reported in the abstract
Loss of hypertension control in patients with baseline hypertension · randomised-withdrawal phase
Odds ratio (95% CI)P value
Between Relacorilant and Placebo
0.17(0.04–0.77)
P = 0.022- Placebo vs Relacorilant
- proportion difference 34%; P = 0.022
Safety
Most common AEs, randomised-withdrawal phase safety population
- Back pain, Relacorilant vs Placebo
- 5 [17%] vs 6 [19%]
- Acne, Relacorilant vs Placebo
- 3 [10%] vs 0
- Arthralgia, Relacorilant vs Placebo
- 3 [10%] vs 3 [9%]
- Bursitis, Relacorilant vs Placebo
- 3 [10%] vs 0
- Headache, Relacorilant vs Placebo
- 3 [10%] vs 4 [13%]
- Insomnia, Relacorilant vs Placebo
- 0 vs 4 [13%]
Adverse events of special interest
- No cases of excessive glucocorticoid receptor antagonism, adrenal insufficiency, vaginal bleeding associated with endometrial hypertrophy, drug-induced hypokalaemia, or drug-induced QT interval prolongation
Original publication
Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study. Lancet Diabetes Endocrinol. Published 20 February 2026. doi:10.
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