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New drug shows promise for cortisol disorder

NCT ID NCT05307328

Disease control Sponsor: Sparrow Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called SPI-62 in 26 adults with Cushing's syndrome caused by a non-adrenal tumor. The goal was to see if SPI-62 could lower cortisol levels safely. Participants received either SPI-62 or a placebo for 24 weeks, with an option to continue longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Sep 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or non-menstruating female * 18 years or older * Active and consistent cortisol excess * Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion. Exclusion Criteria: * Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization. * History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years. * History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions). * High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures. * Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products. * Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.

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Conditions

The condition(s) this trial relates to.

ACTH-dependent Cushing syndrome Cushing disease due to pituitary adenoma Cushing syndrome ectopic ACTH secretion syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cortisol excess Cortisol overproduction Cortisol; hypersecretion Cushing disease due to increased ACTH secretion Cushing's syndrome I Ectopic ACTH secretion

Contacts and locations

Locations

  • Carol Davila University of Medicine and Pharmacy

    Bucharest, 050474, Romania

  • Clinical Center of Endocrinology and Gerontology, University Hospital of Endocrinology, Medical University Sofia (USHATE)

    Sofia, 1431, Bulgaria

  • Comprehensive and Interventional Pain Management Llp

    Henderson, Nevada, 89052, United States

  • Mayo Clinic Cancer Center (MCCC) - Rochester

    Rochester, Minnesota, 55905, United States

  • Medical University of Plovdiv

    Plovdiv, 4002, Bulgaria

  • Medical University of Sofia

    Sofia, 1431, Bulgaria

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Oregon Health & Science University (OHSU) - Northwest Pituitary Center

    Portland, Oregon, 97239, United States

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907, United States

  • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute (BNI) - Pituitary Center

    Phoenix, Arizona, 85013, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Washington University School of Medicine - Center for Advanced Medicine (CAM)

    St Louis, Missouri, 63110, United States

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