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A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease

Trial Profile

A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Osilodrostat (Primary)
  • Indications Cushing syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms LINC-4
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 18 Jun 2023 Results (n=229) of a pooled analysis assessing how dosing, including dose uptitration and adjustments during long-term maintenance, can provide rapid, sustained mUFC control, minimize AEs and improve treatment outcomes from LINC program trials (LINC 2, 3 and 4) presented at the 105th Annual Meeting of the Endocrine Society
    • 18 Jun 2023 Results of pooled analysis (n=56 from studies NCT02180217 and NCT02697734) assessing the efficacy and safety of osilodrostat in pts of Asian and non-Asian origin with CD presented at the 105th Annual Meeting of the Endocrine Society
    • 18 Jun 2023 Results of pooled analysis (n=136 from studies NCT02180217 and NCT02697734) assessing if pts with control of both mUFC and LNSC experienced greater improvements in clinical signs of hypercortisolism and HRQoL, compared to control of mUFC alone presented at the 105th Annual Meeting of the Endocrine Society
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