Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

NCT02804750 | Completed Phase 2 Results DMC

• 1 other identifier: CORT125134-451
• Study Type: interventional
• Target: 35
• Locations: 5 countries
• Sites: 25

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With One or More Adverse Events

  All treatment-emergent adverse events were recorded and summarized.

  Group 1: up to Week 16; Group 2: up to Week 20

• 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.

  Group 1: up to Week 16; Group 2: up to Week 20

Secondary Outcomes (2)

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

  Group 1: Week 12 or last observation; Group 2: Week 16 or last observation

• Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134

  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)

Study Arms (2)

Group 1: Low-dose Group

EXPERIMENTAL

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.

Drug: CORT125134

Group 2: High-dose Group

EXPERIMENTAL

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.

Drug: CORT125134

Interventions

CORT125134 DRUG

Group 1: Low-dose Group; Group 2: High-dose Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has non-endogenous source of hypercortisolemia
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
• Has poorly controlled hypertension
• Has Stage ≥ 4 renal failure

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (25)

Unknown Facility

Laguna Hills, California, 92653, United States

Location

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Aurora, Colorado, 80045, United States

Location

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Fort Lauderdale, Florida, 33312, United States

Location

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Miami, Florida, 33136, United States

Location

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Indianapolis, Indiana, 46202, United States

Location

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Covington, Kentucky, 41011, United States

Location

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Rochester, Minnesota, 55905, United States

Location

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St Louis, Missouri, 63110, United States

Location

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New York, New York, 10016, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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Pittsburgh, Pennsylvania, 15212, United States

Location

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Richmond, Virginia, 23119, United States

Location

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Budapest, Hungary

Location

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Pécs, Hungary

Location

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Cuneo, Italy

Location

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Messina, Italy

Location

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Milan, Italy

Location

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Naples, Italy

Location

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Orbassano, Italy

Location

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Roma, Italy

Location

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Siena, Italy

Location

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Torino, Italy

Location

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Leiden, Netherlands

Location

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Rotterdam, Netherlands

Location

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Salford, Manchester, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35058882 DERIVED

• 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.

  PMID: 34335465 DERIVED

MeSH Terms

Conditions

Cushing Syndrome; Pituitary ACTH Hypersecretion; ACTH Syndrome, Ectopic; Diabetes Mellitus, Type 2; Hypertension; Adrenocortical Carcinoma; Adrenal Cortex Neoplasms

Interventions

relacorilant

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics

info@corcept.com

650-327-3270

Study Officials

• Andreas G Moraitis, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 15, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8); US (12); NL (2); GB (1); HU (2)