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NCT05307328 · ClinicalTrials.gov registry record · Phase 2
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome
A Phase 2 study, sponsored by Sparrow Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT05307328: Completed Phase 2 study, sponsored by Sparrow Pharmaceuticals.
NCT05307328 is a Phase 2 study that has completed, run by Sparrow Pharmaceuticals. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05307328, a Phase 2 study, has completed, sponsored by Sparrow Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
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.
Primary Outcome
The urinary HSD-1 ratio (tetrahydrocortisol + allotetrahydrocortisol ) / tetrahydrocortisone will be used as a biomarker of HSD-1 activity in liver. The primary analysis will include only subjects with Cushing's disease.
Interventions
- DRUG Placebo
- DRUG SPI-62
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 2 |
What the finished NCT05307328 record still lists
NCT05307328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05307328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05307328 about?
NCT05307328 is a clinical study titled "SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome". 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.
What is the current status of trial NCT05307328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-09-01. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT05307328?
The interventions under investigation include: Placebo (DRUG), SPI-62 (DRUG).
Who is sponsoring clinical trial NCT05307328?
This trial is sponsored by Sparrow Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05307328's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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