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NCT05772169 · ClinicalTrials.gov registry record · Phase 4
Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)
A Phase 4 study, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,113
- Enrollment target
NCT05772169: Completed Phase 4 study, sponsored by Corcept Therapeutics.
NCT05772169 is a Phase 4 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 1,113 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05772169, a Phase 4 study, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,113 participants
- Enrollment target
Study Summary
This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult to control T2D despite receiving standard of care therapies.
Primary Outcome
Prevalence (percentage) of patients with hypercortisolism defined by dexamethasone suppression test (DST) \>1.8 μg/dL with dexamethasone level ≥140 ng/dL in patients with difficult to control T2D, defined as HbA1c ≥7.5%. despite receiving standard-of-care therapies.
Interventions
- DRUG Mifepristone 300 MG [Korlym]
- DRUG Placebo for mifepristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,113 participants |
| Start Date | 2023-03-31 |
| Est. Completion | 2024-12-18 |
| Phase | Phase 4 |
What the finished NCT05772169 record still lists
NCT05772169 is an interventional study that assigns participants to a tested intervention. Its 1,113 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (115% higher).
The record links to 0 conditions, and to 2 interventions - of which Mifepristone 300 MG [Korlym] is the first listed.
NCT05772169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05772169 about?
NCT05772169 is a clinical study titled "Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifepristone) (CATALYST)". This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) is a ...
What is the current status of trial NCT05772169?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,113 participants. The study started on 2023-03-31. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT05772169?
The interventions under investigation include: Mifepristone 300 MG [Korlym] (DRUG), Placebo for mifepristone (DRUG).
Who is sponsoring clinical trial NCT05772169?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05772169's enrollment target sits among peer trials
1,113 65th of 2000 higher than 1,936 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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