Not recruiting

Study of SPI-62 for Treating Cushing's Syndrome in Patients with Benign Adrenal Tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Hypercortisolism, which is related to a non-cancerous growth in the adrenal gland. The adrenal glands are small organs located on top of the kidneys that produce hormones, including cortisol. In some cases, these glands can produce too much cortisol, leading to hypercortisolism. This condition can cause various health issues, such as high blood sugar, high blood pressure, and weakened bones. The trial will investigate the effects of a new treatment called SPI-62, which is taken as a film-coated tablet.

The purpose of the study is to evaluate the benefits and risks of using SPI-62 in people who have complications due to hypercortisolism. Participants in the study will receive either the new treatment or a placebo. The study will last for a period of up to 78 weeks, during which participants will be monitored for any changes in their condition and any side effects they may experience. The goal is to see if SPI-62 can help manage the symptoms of hypercortisolism and improve the overall health of the participants.

Throughout the study, researchers will collect information on how the treatment affects various symptoms of hypercortisolism, such as high blood sugar, high cholesterol, and high blood pressure. They will also look at the long-term safety of the treatment, focusing on any serious health issues that may arise. This information will help determine if SPI-62 is a safe and effective option for people with hypercortisolism related to benign adrenal tumors.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants are required to provide informed consent. This involves understanding the study's purpose and agreeing to follow necessary precautions, especially regarding reproductive health.
Step 2
Initial assessment
Participants undergo an initial assessment to confirm the presence of a benign adrenal tumor with proven autonomous cortisol secretion (ACS). This includes diagnostic tests as per current guidelines.
Step 3
Eligibility confirmation
Eligibility is confirmed based on documentation of treatment for, or evidence of, ongoing metabolic issues such as high blood sugar, high blood pressure, high cholesterol, or bone density loss due to significant hypercortisolism.
Step 4
Treatment discussion
Surgery as a first-line therapy is discussed with all eligible participants. Inclusion in the study is only for those who have either failed or rejected available surgical or medical therapies approved in their region.
Step 5
Medication administration
Participants receive the medication SPI-62 in the form of a film-coated tablet. The medication is taken orally. The dosage and frequency are determined by the study protocol and are tailored to each participant's needs.
Step 6
Monitoring and evaluation
Participants are monitored for the benefit-risk profile of SPI-62. This includes laboratory data and the incidence of any treatment-emergent adverse events. The progression or regression of the underlying disease or its complications is also evaluated.
Step 7
Secondary assessments
Secondary assessments focus on the short-term progression, persistence, improvement, or resolution of clinical signs and symptoms of hypercortisolism. This includes monitoring high blood sugar, cholesterol issues, bone density, and blood pressure.
Step 8
Long-term safety evaluation
Long-term safety is assessed in relation to serious health issues or mortality. This ensures that the treatment does not lead to significant health risks over time.
Step 9
Study duration
The study is estimated to conclude by December 1, 2029. Participants are involved in the study for its entire duration unless specific circumstances require earlier withdrawal.

Who can join the trial?

4 criteria

Adult participants who can give their permission to join the study and agree to follow necessary safety measures related to reproduction.
Participants with non-cancerous growths on the adrenal gland that cause **autonomous cortisol secretion (ACS)**, which means the adrenal gland releases cortisol without the usual control signals. This must be confirmed by medical tests.
Participants must have records showing treatment for, or ongoing issues with, at least one of the following conditions due to high cortisol levels: high blood sugar (**hyperglycemia**), high blood pressure (**hypertension**), high cholesterol levels (**hyperlipidemia**), or reduced bone density (**osteopenia**).
Surgery as the first treatment option should be discussed with all participants. They can join the study only if they have not succeeded with or have chosen not to undergo available surgical or medical treatments in their area.

Who cannot join the trial?

6 criteria

Patients who do not have **hypercortisolism** related to a **benign adrenal tumor**. Hypercortisolism is a condition where the body produces too much cortisol, a hormone that helps control stress, blood sugar, and other important functions. A benign adrenal tumor is a non-cancerous growth on the adrenal gland, which is located above the kidneys.
Patients who are not experiencing complications due to **autonomous cortisol secretion (ACS)**. ACS is when the adrenal glands produce cortisol without the usual control signals from the brain.
Patients who are not being managed under the **standard of care**. This means they are not receiving the usual treatment or management for their condition.
Patients who are not within the specified age range for the study. The study includes certain age groups, and those outside these groups cannot participate.
Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of patients, and those not in these groups are excluded.
Patients who are not part of the vulnerable population selected for the study. Vulnerable populations may include groups like children, pregnant women, or others who need special consideration.

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Verified sites

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Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Verified
Brasov, Romania

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Investigated drugs

SPI-62 is a medication being studied for its potential to treat hypercortisolism, which is a condition characterized by excessive levels of cortisol in the body. This condition is related to a benign adrenal tumor. The trial aims to evaluate the benefits and risks of using SPI-62 in patients who experience complications from this condition while they are receiving standard care.

4-{5-[2-(4-Chloro-2,6-Difluorophenoxy)Propan-2-Yl]-4-Methyl-4H-1,2,4-Triazol-3-Yl}-3-Fluorobenzamide

What is already known about the treatment

SPI-62 – SPI-62 is administered orally and is currently being studied in clinical trials as a treatment for hypercortisolism related to benign adrenal tumors. The medication is in the investigational stage, with ongoing research to evaluate its benefits and risks in patients experiencing complications from excessive cortisol production. It is primarily indicated for conditions involving abnormal cortisol levels, such as those caused by benign adrenal tumors. At the molecular level, SPI-62 works by inhibiting specific enzymes involved in cortisol synthesis, thereby reducing cortisol production. It is classified pharmacologically as a cortisol synthesis inhibitor.

Investigated diseases

Hypercortisolism related to benign adrenal tumor – This condition occurs when a benign tumor in the adrenal gland causes an overproduction of cortisol, a hormone that regulates various body functions. The excess cortisol can lead to symptoms such as weight gain, high blood pressure, and changes in skin appearance. Over time, individuals may experience muscle weakness, mood changes, and increased blood sugar levels. The condition can also result in bone thinning and increased risk of fractures. It is important to monitor and manage these symptoms to prevent further complications.