ECEESPE2025 Poster Presentations Adrenal and Cardiovascular Endocrinology (169 abstracts)
Medical treatment of hypercortisolism with relacorilant: Final results of the phase 3 GRACE study
Rosario Pivonello 1 , Giorgio Arnaldi 2 , Richard Auchus 3 , Corin Badiu 4 , Robert Busch 5 , Salvatore Cannavò 6 , Ulrich Dischinger 7 , Georgiana Dobri 8 , Diane Donegan 9 , Atanaska Elenkova 10 , Pouneh Fazeli 11 , Richard Feelders 12 , Rogelio Garcia-Centeno 13 , Aleksandra Gilis-Januszewska 14 , Oksana Hamidi 15 , Zeina Hannoush 16 , Harold Miller 17 , Aurelian E Ranetti 18 , Monica Recasens 19 , Martin Reincke 20 , Sergio Rovner 21 , Roberto Salvatori 22 , Julie M Silverstein 23 , Antonio Stigliano 24 , Massimo Terzolo 25 , Christina Wang 26 , Kevin Yuen 27 , Austin Hand 28 , Iulia Cristina Tudor 28 , Katherine Araque 28 & Andreas G Moraitis 28
1Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Diabetologia, Andrologia e Nutrizione Università Federico II di Napoli, Naples, Italy; 2Endocrinologia, Dipartemento PROMISE, Università degli Studi di Palermo, Palermo, Italy; 3Departments of Pharmacology & Internal Medicine, Division of Metabolism, Endocrinology, & Diabetes, University of Michigan, Ann Arbor, MI, USA; 4“Carol Davila” University of Medicine and Pharmacy and National Institute of Endocrinology, Bucharest, Romania; 5Albany Medical College, Community Endocrine Group, Albany, NY, USA; 6Endocrine Unit, University Hospital G. Martino, University of Messina, Messina, Italy; 7Department of Internal Medicine, Division of Endocrinology and Diabetes, University Hospital of Würzburg, Würzburg, Germany; 8Weill Cornell Medicine, New York, NY, USA; 9Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA; 10USHATE “Acad. Ivan Penchev” Department of Endocrinology, Medical University-Sofia, Sofia, Bulgaria; 11Neuroendocrinology Unit, Division of Endocrinology and Metabolism, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 12Erasmus Medical Center, Department of Internal Medicine, Division of Endocrinology, Rotterdam, Netherlands; 13Endocrinology Department, Gregorio Marañon Hospital, Madrid, Spain; 14Department of Endocrinology, Jagiellonian University, Medical College, Krakow, Poland; 15University of Texas Southwestern Medical Center, Dallas, TX, USA; 16Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism, University of Miami, Miami, FL, USA; 17Diabetes & Metabolism Associates, Covington, LA, USA; 18Central Military University Emergency Hospital “Carol Davila”, Bucharest, Romania; 19Endocrinology Unit, Hospital Josep Trueta de Girona, Girona, Spain; 20Medical Department IV, LMU Klinikum, LMU Munich, Munich, Germany; 21Frontier Medical Center, El Paso, TX, USA; 22Division of Endocrinology Diabetes and Metabolism Johns Hopkins University, Baltimore, MD, USA; 23Washington University School of Medicine; Division of Endocrinology, Metabolism & Lipid Research, St. Louis, MO, USA; 24Endocrinology, Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; 25Department of Clinical and Biological Sciences, University of Turin, Turin, Italy; 26Clinical and Translational Science Institute, The Lundquist Institute at Harbor-UCLA Medical Center, Los Angeles, CA, USA; 27Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, AZ, USA; 28Corcept Therapeutics Incorporated, Redwood City, CA, USA
JOINT1521
Relacorilant is a selective glucocorticoid receptor modulator in development for the treatment of patients with endogenous hypercortisolism. The objective of the phase 3, randomized-withdrawal (RW) GRACE study (NCT03697109) was to assess the efficacy and safety of relacorilant in patients with hypercortisolism and hypertension and/or hyperglycemia (diabetes/impaired glucose tolerance). Patients who achieved prespecified response criteria in the 22-week open-label (OL) phase were then eligible to enter the 12-week, double-blind placebo-controlled RW phase. The primary endpoint was defined as loss of response in hypertension control between relacorilant and placebo and was assessed at the end of the RW phase. There were 152 patients enrolled in GRACE (n=31 with hypertension; n=50 with hyperglycemia; n=71 with both). During the OL phase, rapid and sustained improvements in hypertension and hyperglycemia were observed, along with improvements in several other cortisol-related comorbidities. Patients who continued to receive relacorilant in the RW phase maintained significant improvements in blood pressure and glycemic measures. The primary endpoint was met with an odds ratio of 0.17 (95% confidence interval: 0.04–0.77; P=0.02) in favor of relacorilant. The most common adverse events (AEs) observed were back pain, headache, arthralgia, insomnia, and pain in extremity; these AEs were mostly mild to moderate in severity. No cases of relacorilant-induced irregular vaginal bleeding with endometrial hyperplasia, adrenal insufficiency, or QT prolongation were reported. Significant and sustained improvements in hypertension, hyperglycemia, and other manifestations of cortisol excess were observed during relacorilant treatment. Treatment with relacorilant was well tolerated in both the OL and RW phases of GRACE.
Volume 110
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Endocrine Abstracts
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