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SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

NCT05436639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-13

No results posted yet for this study

Summary

This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.

Conditions

  • Autonomous Cortisol Secretion (ACS)
  • ACTH-Independent Cushing Syndrome
  • ACTH-Independent Adrenal Cushing Syndrome, Somatic

Interventions

DRUG

SPI-62 dose

SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg).

Sponsors & Collaborators

  • Sparrow Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Frank Czerwiec, MD · Sparrow Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-12-01
Completion
2025-02-18
FDA Drug
Yes

Countries

  • United States
  • Romania
  • United Kingdom

Study Locations

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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 NCT05436639 on ClinicalTrials.gov