NCT07247162

Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome

A Double-blind, Randomised, 30-week Placebo-controlled Phase IV Study to Assess the Efficacy and Safety of Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.

Conditions

• Hypertension
• Hypercortisolemia
• Cushing Syndrome

Interventions

Type	Name	Description
DRUG	Osilodrostat	Osilodrostat tablets 1 mg and 5 mg for oral useOsilodrostat tablets 1 mg and 5 mg for oral use.During the 18-week titration phase, the dose of the medication will be titrated every 3 weeks based on the cortisolaemic and clinical response to treatment. An independent endocrinologist titration committee will be applied to provide recommendations on dose-titration based on biochemical and clinical response. At the end of the 18-week dose titration phase, participants will enter a 12-week dose maintenance phase, which is also blinded. They will continue with the dose they were receiving at the end of the dose titration phase, unless there is a need to down-titrate or to stop the study medication for safety purposes.
DRUG	Placebo	matching placebo

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-05-01
• Completion: 2028-07-01
• First posted: 2025-11-25
• Last updated: 2025-12-10

Regulatory

• FDA-regulated drug study