What side effects are associated with this type of intervention?

Common treatments for Autonomous Cortisol Secretion, such as corticosteroid synthesis inhibitors like aminoglutethimide, can lead to side effects including inhibition of corticosterone synthesis, which may result in symptoms of adrenal insufficiency. These symptoms can include fatigue, weakness, nausea, and hypotension. Additionally, glucocorticoid treatments, often used in managing cortisol-related conditions, can cause hyperglycemia, increased susceptibility to infections, bone loss, fractures, and neuropsychiatric side effects such as mood swings and insomnia.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of conditions involving excessive cortisol production, such as Cushing's syndrome. These include ketoconazole, metyrapone, and mitotane, which inhibit cortisol synthesis. Mifepristone, a glucocorticoid receptor antagonist, is also approved for controlling hyperglycemia secondary to hypercortisolism. These treatments aim to reduce cortisol levels or block its effects, similar to the mechanism of action being studied for SPI-62.

What other types of research exist?

Promising alternatives to SPI-62 for treating autonomous cortisol secretion include RU 486 (mifepristone), which has shown efficacy in normalizing clinical and biochemical features of hypercortisolism by antagonizing cortisol action. Additionally, novel melanocortin type 2 receptor antagonists like GPS1573 and GPS1574, which have been tested in vivo for their effects on corticosterone response, may offer new therapeutic avenues.

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SPI-62 for Cushing's Syndrome (ACSPIRE Trial)

Phase 2

Waitlist Available

Research Sponsored by Sparrow Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant

Be older than 18 years old

Must not have

Positive test for severe acute respiratory syndrome coronavirus 2 infection within 4 weeks, or hospitalization for Coronavirus disease 2019 within 6 months, prior to randomization

Uncontrolled, clinically significant hypo- or hyperthyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests SPI-62, a medication for people with high cortisol due to a benign adrenal tumor. It aims to lower cortisol levels to improve health issues like diabetes, high cholesterol, high blood pressure, and weak bones.

Who is the study for?

This trial is for adults with a benign adrenal tumor causing high cortisol levels, which may lead to conditions like diabetes or high blood pressure. Participants should have stable health conditions and not be pregnant, lactating, or have had recent major surgery. They shouldn't have other forms of Cushing's syndrome or certain cancers within the last 3 years.

What is being tested?

The study tests SPI-62 at various doses to see if it can safely treat hypercortisolism due to a benign adrenal tumor. Each participant will take a daily dose of SPI-62 (2mg) and their response will be monitored for effectiveness and safety.

What are the potential side effects?

While specific side effects of SPI-62 are not listed here, common side effects from treatments targeting cortisol levels include fatigue, nausea, changes in blood pressure or blood sugar levels, mood swings, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My adrenal nodule is non-cancerous, smaller than 4 cm, and has a uniform texture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I tested positive for COVID-19 within the last 4 weeks or was hospitalized for it within the last 6 months.

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My thyroid condition is not under control.

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I have been diagnosed with a condition that affects my adrenal glands or causes high cortisol levels.

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I have not had major surgery in the last month and do not plan any during the trial.

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I have high cortisol levels not caused by my body.

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I have a history of low platelet counts without a known cause.

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I haven't had cancer (except for certain skin, thyroid, or early prostate cancer) in the last 3 years.

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My kidney function is moderately impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c at Week 6

Change in HbA1c at week 12

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SPI-62 doseExperimental Treatment1 Intervention

2mg dose level of SPI-62. Active drug by mouth.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corticosteroid synthesis inhibitors, such as those being studied in the trial SPI-62, work by blocking the enzymes responsible for cortisol production. This reduction in cortisol levels is essential for patients with Autonomous Cortisol Secretion, as excessive cortisol can cause significant health problems including hypertension, diabetes, and osteoporosis. By inhibiting cortisol synthesis, these treatments help manage and mitigate the adverse effects associated with high cortisol levels, improving patient outcomes and quality of life.