SPI-62 for Cushing's Syndrome

(ACSPIRE Trial)

Recruiting at 84 trial locations

Overseen By Sarah Hooper

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sparrow Pharmaceuticals

Disqualifiers: Cushing's syndrome, Adrenalectomy, Thyroid disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Frank Czerwiec, MD

Principal Investigator

Sparrow Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

I have high cholesterol, high triglycerides, weak bones, a history of fractures, or high blood pressure related to cortisol.

I am an adult who can understand and agree to the study's details.

I have diabetes or pre-diabetes with specific blood sugar levels.

Exclusion Criteria

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

My thyroid condition is not under control.

Pregnant or lactating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 2mg of SPI-62 daily to evaluate its effect on hypercortisolism

12 months

Visits at baseline, months 1, 3, 6, 9, 12, and then quarter-annually

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Placebo
• SPI-62

Trial Overview 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.

Participant Groups

Group I: SPI-62 dose Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sparrow Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

160+