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NCT Number: NCT02804750

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

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.

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Key information

Conditions

Cushing's Syndrome ACTH Syndrome, Ectopic Adenocarcinoma Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Adrenocortical Hyperfunction Brain Diseases Carcinoma Cardiovascular Diseases Central Nervous System Diseases Cushing Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Hyperpituitarism Hypertension Hypothalamic Diseases Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Nutritional and Metabolic Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pituitary ACTH Hypersecretion Pituitary Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CORT125134

Drug

Primary outcomes

  1. Percentage of Participants With One or More Adverse Events

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

    All treatment-emergent adverse events were recorded and summarized.

  2. 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

    All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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