A Multicenter, Phase 2/3, Dose Range Finding Study to Evaluate the Efficacy and Safety of Atumelnant in Adults with ACTH-Dependent Cushing’s Syndrome (ADCS) Including an Open-Label Extension for Long-Term Assessment. (EQUILIBRIUM-ADCS)

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522648-42-01

Enrollment

Registered

2026-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• ACTH-Dependent Cushing’s Syndrome. • Pituitary-dependent Cushing´s syndrome.

Brief summary

Proportion of participants with mUFC ≤ULN at Week 12

Detailed description

Change from baseline to Week 12: mUFC, AM serum cortisol, Late-night (approximately 22:00) salivary cortisol., Change from baseline in QoL at Week 12.

Interventions

DRUGEncorton

DRUG5 mg

DRUGtabletki

DRUGPrednisone placebo

DRUGAcecort 5 mg Filmtabletten

DRUGAtumelnant 20 mg tablets

DRUGAtumelnant placebo for doses 20mg

DRUG40mg

DRUG80mg and 120mg

DRUG1 mg

DRUGAtumelnant 120 mg tablets

DRUGHydrocortisonum-SF

DRUG10 mg

DRUGAtumelnant 80 mg tablets

DRUGAtumelnant 40 mg tablet

DRUGHydrocortisone placebo

DRUGSolu-Cortef

DRUGpoeder voor injectievloeistof

DRUG100 mg + oplosmiddel (“Act-O-Vial”)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants with mUFC ≤ULN at Week 12	—

Secondary

Measure	Time frame
Change from baseline to Week 12: mUFC, AM serum cortisol, Late-night (approximately 22:00) salivary cortisol., Change from baseline in QoL at Week 12.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 30, 2026