Phase 2
N=35
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Cushing's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02804750 ↗Enrolled (actual)
35
Serious AEs
11.4%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Participants With One or More Adverse Events — 15; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CORT125134 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corcept Therapeutics
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With One or More Adverse Events |
15; 18 | — |
| PRIMARY Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events |
3; 7 | — |
| SECONDARY Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134 |
41.67; 63.64 | — |
| SECONDARY Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134 |
23.08; 0 | — |
Summary
Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol.
Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, were not eligible for enrollment in this study.
The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study was conducted in the United States and in Europe.
Eligibility Criteria
Inclusion Criteria
- Has a confirmed diagnosis of endogenous Cushing's syndrome.
- Requires medical treatment of hypercortisolemia.
- Meets at least one of the following criteria:
- Has type 2 diabetes mellitus.
- Has impaired glucose tolerance.
- Has hypertension.
Exclusion Criteria
- Has non-endogenous source of hypercortisolemia
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage ≥ 4 renal failure
Data sourced from ClinicalTrials.gov (NCT02804750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.