{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T14:15:39Z","timestamp":1793196939119,"version":"4.5.0"},"reference-count":43,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,7,14]],"date-time":"2021-07-14T00:00:00Z","timestamp":1626220800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction\/Purpose<\/jats:title>\n                    <jats:p>Relacorilant is a selective glucocorticoid receptor modulator (SGRM) with no progesterone receptor activity. We evaluated the efficacy and safety of relacorilant in patients with endogenous Cushing syndrome (CS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      A single-arm, open-label, phase 2, dose-finding study with 2 dose groups (NCT02804750,\n                      <jats:uri>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02804750<\/jats:uri>\n                      ) was conducted at 19 sites in the U.S. and Europe. Low-dose relacorilant (100-200 mg\/d; n = 17) was administered for 12 weeks or high-dose relacorilant (250-400 mg\/d; n = 18) for 16 weeks; doses were up-titrated by 50 mg every 4 weeks. Outcome measures included proportion of patients with clinically meaningful changes in hypertension and\/or hyperglycemia from baseline to last observed visit. For patients with hypertension, clinical response was defined as a \u22655-mmHg decrease in mean systolic or diastolic blood pressure, measured by a standardized and validated 24-h ABPM. For patients with hyperglycemia, clinical response was defined ad-hoc as \u22650.5% decrease in HbA1c, normalization or \u226550-mg\/dL decrease in 2-h plasma glucose value on oral glucose tolerance test, or decrease in daily insulin (\u226525%) or sulfonylurea dose (\u226550%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>35 adults with CS and hypertension and\/or hyperglycemia (impaired glucose tolerance or type 2 diabetes mellitus) were enrolled, of which 34 (24 women\/10 men) received treatment and had postbaseline data. In the low-dose group, 5\/12 patients (41.7%) with hypertension and 2\/13 patients (15.4%) with hyperglycemia achieved response. In the high-dose group, 7\/11 patients (63.6%) with hypertension and 6\/12 patients (50%) with hyperglycemia achieved response. Common (\u226520%) adverse events included back pain, headache, peripheral edema, nausea, pain at extremities, diarrhea, and dizziness. No drug-induced vaginal bleeding or hypokalemia occurred.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The SGRM relacorilant provided clinical benefit to patients with CS without undesirable antiprogesterone effects or drug-induced hypokalemia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fendo.2021.662865","type":"journal-article","created":{"date-parts":[[2021,7,14]],"date-time":"2021-07-14T09:05:43Z","timestamp":1626253543000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":73,"title":["Relacorilant, a Selective Glucocorticoid Receptor Modulator, Induces Clinical Improvements in Patients With Cushing Syndrome: Results From A Prospective, Open-Label Phase 2 Study"],"prefix":"10.3389","volume":"12","author":[{"given":"Rosario","family":"Pivonello","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Bancos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.","family":"Feelders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atil Y.","family":"Kargi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice M.","family":"Kerr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray B.","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cary 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