Ongoing Clinical Trials for Hyperadrenocorticism
There is currently 1 ongoing clinical trial investigating new treatments for hyperadrenocorticism (also known as Cushing’s syndrome, hypercortisolism). This trial is being conducted in Romania and focuses on patients with benign adrenal tumors that cause excessive cortisol production. The investigational treatment being studied is SPI-62, an oral medication designed to reduce cortisol levels by blocking specific enzymes involved in its production.
Clinical trial locations
Study of SPI-62 for Treating Cushing’s Syndrome in Patients with Benign Adrenal Tumors
This trial is investigating SPI-62, a film-coated tablet taken by mouth, for treating patients who have benign (non-cancerous) adrenal tumors that produce too much cortisol. The adrenal glands sit on top of the kidneys and make important hormones, including cortisol. When these glands produce excessive cortisol, it leads to various health problems such as high blood sugar, high blood pressure, weakened bones, and high cholesterol.
Main inclusion criteria:
- Adults who can provide informed consent and follow reproductive safety measures
- Confirmed diagnosis of a benign adrenal tumor causing autonomous cortisol secretion (meaning the adrenal gland releases cortisol without normal control signals)
- Documentation of treatment for, or ongoing problems with, at least one of these conditions caused by high cortisol: high blood sugar, high blood pressure, high cholesterol, or reduced bone density
- Surgery must have been discussed as a first treatment option, and participants can only join if they have not succeeded with, or have chosen not to undergo, available surgical or medical treatments in their area
Main exclusion criteria:
- Patients without hypercortisolism related to a benign adrenal tumor
- Patients not experiencing complications from autonomous cortisol secretion
- Patients not receiving standard care management for their condition
- Patients outside the specified age range for the study
- Patients not belonging to the specific clinical trial groups identified for this research
Focus and goal of the trial:
The study aims to evaluate whether SPI-62 is safe and effective in managing symptoms of hypercortisolism in people with benign adrenal tumors. Researchers will monitor how the treatment affects various complications such as high blood sugar, high cholesterol, high blood pressure, and bone density loss. The trial will assess both short-term improvements in symptoms and long-term safety, including any serious health issues that may develop. Participants will receive either SPI-62 or a placebo and will be followed for up to 78 weeks. The study is expected to conclude by December 1, 2029.
Investigational drug:
SPI-62 is an oral medication that works by blocking specific enzymes involved in cortisol production, thereby reducing the amount of cortisol made by the adrenal glands. It is classified as a cortisol synthesis inhibitor and is currently in the investigational stage, meaning it is still being studied to determine its benefits and risks before it can be approved for general use.
Summary
Currently, only one clinical trial is recruiting patients with hyperadrenocorticism caused by benign adrenal tumors. This trial is being conducted in Romania and focuses on patients who have already experienced metabolic complications from excessive cortisol production and for whom surgery is not a suitable option. The investigational drug SPI-62 represents a potential new approach to managing this condition by directly reducing cortisol production at the enzyme level. The study’s comprehensive evaluation period of up to 78 weeks will provide important information about both the immediate symptom relief and long-term safety of this treatment approach.
