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Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

Primary Purpose

Cushing's Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CORT125134
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing's Syndrome focused on measuring Cushing's Syndrome, Cushing's Disease, Cushing's, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Low-dose Group

Group 2: High-dose Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With One or More Adverse Events
All treatment-emergent adverse events were recorded and summarized.
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.

Secondary Outcome Measures

Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
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
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.

Full Information

First Posted
June 15, 2016
Last Updated
October 7, 2019
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02804750
Brief Title
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Official Title
Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This was a Phase 2, open-label study with two dose groups, each with a two-step dose escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of endogenous Cushing's syndrome. CORT125134 was administered orally once daily for 16 weeks with dose escalations occurring every 4 weeks. Pharmacokinetics (PK) profiles were generated at every dose level. A data review committee reviewed PK and safety data and recommended the final plan for dose escalation in Group 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Syndrome
Keywords
Cushing's Syndrome, Cushing's Disease, Cushing's, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Low-dose Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: High-dose Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CORT125134
Primary Outcome Measure Information:
Title
Percentage of Participants With One or More Adverse Events
Description
All treatment-emergent adverse events were recorded and summarized.
Time Frame
Group 1: up to Week 16; Group 2: up to Week 20
Title
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events
Description
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
Time Frame
Group 1: up to Week 16; Group 2: up to Week 20
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
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.
Time Frame
Group 1: Week 12 or last observation; Group 2: Week 16 or last observation
Title
Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas G Moraitis, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Covington
State/Province
Kentucky
ZIP/Postal Code
41011
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23119
Country
United States
City
Budapest
Country
Hungary
City
Pecs
Country
Hungary
City
Cuneo
Country
Italy
City
Messina
Country
Italy
City
Milano
Country
Italy
City
Naples
Country
Italy
City
Orbassano
Country
Italy
City
Roma
Country
Italy
City
Siena
Country
Italy
City
Torino
Country
Italy
City
Leiden
Country
Netherlands
City
Rotterdam
Country
Netherlands
City
Salford
State/Province
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35058882
Citation
Pivonello 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.
Results Reference
derived
PubMed Identifier
34335465
Citation
Pivonello 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. Erratum In: Front Endocrinol (Lausanne). 2022 Apr 27;13:899616.
Results Reference
derived

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Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

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