Primary outcomeCount of participants· Group 1: up to Week 16; Group 2: up to Week 20
Percentage of Participants With One or More Adverse Events
| Group | Value (Participants) |
|---|---|
| Group 1: Low-dose Group | 15 |
| Group 2: High-dose Group | 18 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataStudy to Evaluate CORT125134 in Participants With Cushing's Syndrome
NCTNCT02804750 (opens ClinicalTrials.gov in a new tab)Other idCORT125134-451
This trial does not test a peptide that PepBank tracks.
- Names ACTH (corticotropin), does not test it. It appears in the conditions.
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 35 participants (actual)
- Sponsor
- Corcept Therapeutics · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
5 countries
United States, Hungary, Italy, Netherlands, United Kingdom
- Start
- Jun 2016
- Primary completion
- Sept 2018
- Completion
- Sept 2018
- First posted
- 17 Jun 2016 (estimated)
- Last update posted
- 15 Oct 2019
- Conditions
- Cushing's Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019
- Ph 2
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
NCT02804750Jun 2016 to Sept 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CORT125134Drug
Arms2
Experimental
Group 1: Low-dose Group
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.
Experimental
Group 2: High-dose Group
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
Primary outcomes2
Outcomes the sponsor listed as primary.
Percentage of Participants With One or More Adverse Events
Time frame · Group 1: up to Week 16; Group 2: up to Week 20
Registry description
All treatment-emergent adverse events were recorded and summarized.
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events
Time frame · Group 1: up to Week 16; Group 2: up to Week 20
Registry description
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
Secondary outcomes(2)
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
Time frame · Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
Registry description
Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.
Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
Time frame · Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
Registry description
Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· Group 1: up to Week 16; Group 2: up to Week 20
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events
| Group | Value (Participants) |
|---|---|
| Group 1: Low-dose Group | 3 |
| Group 2: High-dose Group | 7 |
Secondary and other outcome results(3)
Secondary outcomeNumber· Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
| Group | Value (Percentage of participants) |
|---|---|
| Group 1: Low-dose Group | 41.67 |
| Group 2: High-dose Group | 63.64 |
Secondary outcomeNumber· Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
| Group | Value (Percentage of participants) |
|---|---|
| Group 1: Low-dose Group | 23.08 |
| Group 2: High-dose Group | 0 |
Post hoc outcomeNumber· Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109
| Group | Value (Percentage of participants) |
|---|---|
| Group 1: Low-dose Group | 15.38 |
| Group 2: High-dose Group | 50.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group 1: Low-dose Group100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. | 0 / 17 | 0 / 17 | 15 / 17 |
| Group 2: High-dose Group250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. | 0 / 18 | 4 / 18 | 18 / 18 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedPivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021. PMID 35058882
- DerivedPivonello R, Bancos I, Feelders RA, Kargi AY, Kerr JM, Gordon MB, Mariash CN, Terzolo M, Ellison N, Moraitis AG. Relacorilant, a Selective Glucocorticoid Receptor Modulator, Induces Clinical Improvements in Patients With Cushing Syndrome: Results From A Prospective, Open-Label Phase 2 Study. Front Endocrinol (Lausanne). 2021 Jul 14;12:662865. doi: 10.3389/fendo.2021.662865. eCollection 2021. PMID 34335465
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Has a confirmed diagnosis of endogenous Cushing's syndrome.
2. Requires medical treatment of hypercortisolemia.
3. Meets at least one of the following criteria:
1. Has type 2 diabetes mellitus.
2. Has impaired glucose tolerance.
3. Has hypertension.
Exclusion Criteria:
1. Has non-endogenous source of hypercortisolemia
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has Stage ≥ 4 renal failure
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