Clinical Trials

Main Inclusion Criteria:

• Adult participants able to give informed consent and willing to adhere to necessary reproductive precautions.
• Participants with benign adrenal lesions(s) with proven ACS (clinical evidence of ACS confirmed by positive diagnostic tests per current guidelines).
• Participants should have documentation of treatment for, or evidence of, ongoing metabolic consequences for at least one of the following: hyperglycemia, hypertension, hyperlipidemia, osteopenia, attributable to clinically significant hypercortisolism.
• Surgery as first-line therapy should be discussed with all eligible participants, who will be included only if they have failed or rejected available surgical or medical therapy(ies) approved in their region of residence.

Main Exclusion Criteria:

• Participants with adrenal Cushing’s syndrome (aCs) will be excluded.
• History of adrenalectomy or planned adrenalectomy within 4 months after enrollment.
• Hypercortisolism which is exogenous including ACTH-dependent, cyclical, intermittent, or physiological (a.k.a. pseudo-Cushing’s).
• Participants who plan to undergo curative adrenal surgery within the next 3 years.
• History of idiopathic thrombocytopenia.
• History of cancer within 3 years likely to require further testing or intervention during the trial period or associate with a poor prognosis (e.g., other than treatable skin, thyroid, or early-stage prostate cancer, please consult with Medical Monitor for others).
• Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
• Pregnant or lactating.
• Other medical contraindications to SPI-62 therapy or other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
• Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a sanitary or social institution for purposes other than research and major persons subject to a legal protection measure.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/20/23. Questions regarding updates should be directed to the study team contact.