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Neuroendocrinology and Pituitary

SAT-036 - Osilodrostat Treatment Outcomes Across Various Etiologies and Severities of Cushing'S Syndrome: LINC 7 Secondary Analysis

Saturday, June 13, 2026
9:30 AM - 4:30 PM CT
Location: ENDOExpo; Poster Floor


Introduction: Endogenous Cushing’s syndrome (CS) is a rare disease caused by excess cortisol production. Most cases (60–70%) are caused by a pituitary adenoma (Cushing’s disease). Other etiologies of CS include ectopic adrenocorticotropic hormone secretion (EAS; 6–10%), adrenal adenomas and carcinomas (20–30%), and bilateral adrenal nodular disease (BND; 5%). LINC 7 (NCT05633953), a retrospective observational study, assessed osilodrostat safety and effectiveness in adrenal and ectopic CS. This secondary analysis evaluated the safety and effectiveness of osilodrostat by etiology and severity of CS.

Methods: Patients (pts) with adrenal or ectopic CS who initiated osilodrostat under the French Autorisation Temporaire d’Utilisation scheme or, once approved, in routine clinical practice were followed up retrospectively for ≤36 months (Tabarin et al. J Clin Endocrinol Metab 2025). Pts were specified as having: (1) mild benign adrenal CS (MbACS; any cortisol measure [ACM; mean urinary free cortisol, late-night salivary cortisol or morning serum cortisol] at baseline [BL] ≤2 times the upper limit of normal [ULN], with adrenal adenoma or BND); (2) mild malignant CS (MmCS; BL ACM ≤2 x ULN, with adrenocortical carcinoma or EAS); or (3) moderate-severe CS (MSCS; ACM >2 x ULN, all aetiologies). Analyses are descriptive only.

Results: 91/103 pts had BL ACM data (MbACS, n=20; MmCS, n=19; MSCS, n=52); mean age was 58, 63 and 57 years, respectively. Initial median (min–max) osilodrostat dose was 4 (1–10; MbACS), 4 (1–40; MmCS) and 10 (2–60; MSCS) mg/day; at week (W)24, this was 4 (1–12), 15 (3–40) and 20 (0–120) mg/day. At W12 and W24, ACM ≤ULN was achieved in n=8/9 and n=4/4 patients with MbACS, respectively; equivalent values were n=7/10 and n=7/7 for MmCS and n=15/28 and n=9/15 for MSCS. Most (n=75/91 [82.4%]) patients had hypertension at BL (MbACS, n=18/20; MmCS, n=17/19; MSCS, n=40/52). Among these patients, mean baseline systolic blood pressure (SBP; mmHg) was 139.9 (MbACS, n=17), 141.1 (MmCS, n=15) and 148.4 (MSCS, n=34). By W24, SBP had decreased in MmCS (130.5, n=6) and MSCS (134.9, n=7) and was 142.0 in MbACS (n=2). Mean baseline fasting plasma glucose (mg/dL) was higher in MSCS (127.9, n=27) than in MbACS (103.4, n=14) or MmCS (98.4, n=11) and decreased in all groups (W24: MSCS, 82.2, n=5; MbACS, 80.7, n=3; MmCS, 81.0, n=7). Hypocortisolism-related adverse events occurred in n=4/20 (MbACS), n=6/19 (MmCS) and n=18/52 (MSCS) pts, most commonly adrenal insufficiency (MbACS, n=4; MmCS, n=6; MSCS, n=16). Deaths were most commonly neoplasm related (MmCS, n=4/10; MSCS, n=4/14); no deaths were reported in MbACS.

Conclusions: Osilodrostat effectively reduced cortisol levels, leading to improvements in cardiometabolic parameters in patients with CS, regardless of etiology or severity and with an expected and manageable safety profile.

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