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SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome

NCT05307328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-10-08

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.

Conditions

  • Cushing's Syndrome I
  • Cushing Disease Due to Increased ACTH Secretion
  • Cortisol Excess
  • Cortisol; Hypersecretion
  • Cortisol Overproduction
  • Ectopic ACTH Secretion

Interventions

DRUG

SPI-62

11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

DRUG

Placebo

Inactive tablets identical to SPI-62 tablets

Sponsors & Collaborators

  • Sparrow Pharmaceuticals

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-08-01
Completion
2025-08-01
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Romania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307328 on ClinicalTrials.gov