Not yet taking people in AustriaPhase 2/3
Atumelnant for adults with ACTH-dependent Cushing's syndrome
Tests atumelnant at different doses in adults with ACTH-dependent Cushing's syndrome.
Key facts
- Who runs it
- Crinetics Pharmaceuticals Inc.
- Where
- Graz and Vienna, AustriaSee the 2 sitesAlso in 7 other countries, 37 sites
- Trial code
- Registry title
- 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
- Phase
- Phase 2/3
- People taking part
- 97 people, planned
- Started
- 31 Oct 2026
- Expected to end
- 31 Mar 2031
- Type of study
- Interventional
- Record updated
- 12 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ACTH-dependent Cushing's syndrome, a condition where too much ACTH hormone drives high cortisol. It tests atumelnant.
- Age
- ≥18 to <75 years. At US sites, people ≥16 years of age may join.
- Sex
- Male or female.
- Disease stage
- Confirmed ACTH-dependent Cushing's syndrome. The ACTH source can be the pituitary, a tumor elsewhere (ectopic), or unknown. Shown by an abnormal dexamethasone suppression test and/or high late-night saliva cortisol in the past, or by tissue proof of an ACTH-producing tumor.
- Earlier treatment
- Current drugs for the condition must be stopped first: 2 weeks for ketoconazole, levoketoconazole or metyrapone; 4 weeks for osilodrostat, mifepristone or cabergoline; 8 weeks for pasireotide LAR. People who took atumelnant before, or ever used mitotane, cannot join. The open-label extension (Part C) is for people from Part A or B, or late screeners.
- Biomarker or test result
- Urine cortisol (mUFC) >1.3×ULN, checked by the central laboratory. Morning plasma ACTH >10 pg/mL.
Main reasons for not taking part
- Pituitary radiation therapy within 3 years of screening
- High-risk pituitary tumor, such as a lesion within 2 mm of the optic chiasm, tumor growth within 1 year after surgery or radiation, or pituitary carcinoma
- Expected need for brain surgery or radiation during the study
- Major surgery or pituitary surgery within 1 month before screening
- Life expectancy of less than 6 months, or an investigational drug within the past 60 days or 5 half-lives
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Part A and Part B Key Inclusion Criteria: 1. Male or female, ≥18 to <75 years of age at the time of signing the ICF. Participants≥16 years of age may be included at sites located in the US. Participants must have confirmed ADCS (pituitary, ectopic, or unknown source of excess ACTH after appropriate investigation) as evidenced by mUFC >1.3×ULN, confirmed by the central laboratory and available before Day 1 using adequate UFC samples as defined in the protocol
- Part C Key Inclusion Criteria: 1. Participants from Part A or Part B who complete the 12-week Treatment Periods on study drug or are rescued due to hypercortisolism and who, in the Investigator’s opinion, may benefit from participation in the OLE
- Part C Key Inclusion Criteria: 2. Late Screeners: When enrollment into Part B is closed, participants who were undergoing screening for Part B and who meet all Part B inclusion criteria may enroll directly into Part C. Participants may initiate Part C once all applicable eligibility criteria are confirmed
- Part A and Part B Key Inclusion Criteria: 2. Documentation of either abnormal dexamethasone suppression test and/or elevated late-night salivary cortisol levels performed historically, or pathologic confirmation of an ACTH-producing tumor
- Part A and Part B Key Inclusion Criteria: 3. Morning plasma ACTH >10 pg/mL
- Part A and Part B Key Inclusion Criteria: 4. Washout of any current drug therapy for ADCS following Screening Visit 1. The following minimum washout periods must be completed before baseline efficacy assessments are performed: • 2 weeks: Ketoconazole, levoketoconazole, or metyrapone. • 4 weeks: Osilodrostat, mifepristone, or cabergoline. • 8 weeks: Pasireotide LAR. Participants who complete the Washout Period and whose mUFC is not >1.3×ULNmay repeat one set of triplicate UFC collections, if deemed safe and clinically appropriate in the Investigator’s opinion
Who cannot take part
- Part A and Part B Key Exclusion Criteria: 9. Participants who have previously taken atumelnant
- Part A and Part B Key Exclusion Criteria: 7. Participants who received pituitary radiation therapy within 3 years of screening
- Part A and Part B Key Exclusion Criteria: 10. Participants who will not benefit from chronic treatment with study drug or have a life expectancy of less than 6 months
- Part A and Part B Key Exclusion Criteria: 11. Clinically significant concomitant disease considered by the Investigator likely to affect safe participation in the study
- Part A and Part B Key Exclusion Criteria: 2. For medically untreated participants at Screening Visit 1, prior use of the following medications within the specified intervals prior to screening: - 2 weeks: Ketoconazole, levoketoconazole, or metyrapone. - 4 weeks: Osilodrostat, mifepristone, or cabergoline. - 8 weeks: Pasireotide LAR. Participants who have not completed the required washout periods are not eligible
- Part A and Part B Key Exclusion Criteria: 3. Use of any investigational drug within the past 60 days or 5 half-lives (whichever is longer) prior to the first dose; or plan to use an investigational drug in another study
- Part A and Part B Key Exclusion Criteria: 5. History of major surgery within 1 month prior to screening
- Part A and Part B Key Exclusion Criteria: 6. Pituitary surgery within 1 month of screening
- Part A and Part B Key Exclusion Criteria: 8. High-risk pituitary tumor pattern as defined by: - Current pituitary MRI findings of a lesion within 2 mm of the optic chiasm. - History of pituitary or ectopic tumor growth within 1 year after surgery(if performed) or radiation (unless it occurred during a period of medical therapy interruption) - Anticipated requirement for neurosurgical intervention or radiation therapy within the time course of the study. - Pituitary carcinoma
- Part A and Part B Key Exclusion Criteria: 1. Known history of, or concern for hypersensitivity reaction to atumelnant or any of its excipients
- Part A and Part B Key Exclusion Criteria: 4. Any history of mitotane use
Where in Austria
Also in 7 other countries, 37 sites
- Medical University of GrazGraz, AustriaNot yet recruiting
- Medical University of ViennaVienna, AustriaNot yet recruiting
About the trial
What the trial wants to find out
To evaluate the effect of atumelnant on mUFC at Week 12
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Atumelnant for adults with ACTH-dependent Cushing's syndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 12 October 2026