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NCT03697109 · REGISTRY CONDITION SEARCH

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-07-16

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.

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outcome · POSTED

Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

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outcome · POSTED

Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase

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outcome · POSTED

Change in Hemoglobin HbA1c During the RW Phase

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outcome · POSTED

Change in 2-hour Plasma Glucose During the RW Phase

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outcome · POSTED

Change in SBP and DBP During the RW Phase

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outcome · POSTED

Change in Body Weight During the RW Phase

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outcome · POSTED

Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase

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outcome · POSTED

Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase

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outcome · POSTED

Percent Change in Tissue Fat Mass During the RW Phase

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outcome · NOT POSTED

Number of Patients Who Worsened, as Assessed by the Global Clinical Response, During the RW Phase

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outcome · POSTED

Change in Percent Tissue Fat Mass During the OL Phase

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outcome · POSTED

Change in Cushing QoL Normalized Total Score During the OL Phase

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outcome · POSTED

Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase

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outcome · POSTED

Mean Change From Baseline in Body Weight During the OL Phase

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outcome · POSTED

Change in 2-hour Plasma Glucose During the OL Phase

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outcome · POSTED

Change in Hemoglobin HbA1c During the OL Phase

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outcome · POSTED

Change in SBP and DBP During the OL Phase

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Has a confirmed diagnosis of endogenous Cushing syndrome * Meets at least 1 of the following criteria: * Has Type 2 diabetes mellitus * Has impaired glucose tolerance * Has hypertension. Exclusion Criteria: * Has non-endogenous source of hypercortisolism * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism * Has poorly controlled hypertension * Has poorly controlled diabetes mellitus * Has severe renal insufficiency.
healthy Volunteers
false
maximum Age
80 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
    intervention Names
    1. Drug: Relacorilant
    label
    Relacorilant (OL Phase)
    type
    EXPERIMENTAL
  2. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.
    intervention Names
    1. Drug: Relacorilant
    label
    Relacorilant (RW Phase)
    type
    EXPERIMENTAL
  3. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.
    intervention Names
    1. Other: Placebo
    label
    Placebo (RW Phase)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Relacorilant (OL Phase)
    2. Relacorilant (RW Phase)
    description
    Relacorilant is supplied as 100 mg capsules for oral dosing.
    name
    Relacorilant
    other Names
    1. CORT125134
    type
    DRUG
  2. arm Group Labels
    1. Placebo (RW Phase)
    description
    Placebo matched to study drug
    name
    Placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
152
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns.
    measure
    Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  2. description
    Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass.
    measure
    Percent Change in Tissue Fat Mass During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  3. description
    The Global Clinical Response assessment measures the patient's signs and symptoms of endogenous hypercortisolism in 7 clinical categories: 1) glucose parameters, 2) blood pressure parameters, 3) body composition parameters, 4) clinical appearance, 5) strength parameters, 6) psychiatric health/cognitive function parameters, and 7) quality of life using the Cushing QoL score. The overall response based on the totality of signs and symptoms is rated as +1 for improved, 0 for unchanged, and -1 for worsened. Each patient's final score is the median of ratings given by 3 members of the Data Review Board.
    measure
    Number of Patients Who Worsened, as Assessed by the Global Clinical Response, During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)
  4. description
    Tissue fat mass was measured by DXA scan.
    measure
    Change in Percent Tissue Fat Mass During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  5. description
    The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns.
    measure
    Change in Cushing QoL Normalized Total Score During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  6. description
    The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression.
    measure
    Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  7. measure
    Mean Change From Baseline in Body Weight During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  8. description
    Plasma glucose was measured using the 2-hour oGTT.
    measure
    Change in 2-hour Plasma Glucose During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  9. measure
    Change in Hemoglobin HbA1c During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
  10. description
    Blood pressure was measured by 24-hour ABPM.
    measure
    Change in SBP and DBP During the OL Phase
    time Frame
    Baseline and Week 22 (end of OL Phase)
primary Outcomes
  1. description
    Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.
    measure
    Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  2. measure
    Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
    time Frame
    OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
secondary Outcomes
  1. measure
    Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase
    time Frame
    Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  2. measure
    Change in Hemoglobin HbA1c During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  3. description
    Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).
    measure
    Change in 2-hour Plasma Glucose During the RW Phase
    time Frame
    Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  4. description
    Blood pressure was measured by 24-hour ABPM.
    measure
    Change in SBP and DBP During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  5. measure
    Change in Body Weight During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
  6. measure
    Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase
    time Frame
    Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase)
Full study description
brief Summary
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).
detailed Description
The primary outcome is the assessment of efficacy of relacorilant treatment based on sustained blood pressure control during the Randomized-withdrawal (RW) Phase, wherein patients who had achieved the blood pressure response criteria during the Open-label (OL) Phase are randomized to receive either relacorilant or placebo for 12 weeks. Patients in the OL Phase will dose-escalate in 100 mg increments to a maximum dose of 400 mg orally once daily. Patients will remain on OL treatment until Week 22 at which time they will be evaluated for the RW Phase based on predefined hyperglycemia and hypertension response criteria. Eligible patients will then be randomized to receive either relacorilant or placebo at a 1:1 ratio for 12 weeks. Patients who do not meet the criteria for the RW Phase will end treatment and may be eligible to roll over into an extension safety study. Patients who complete the RW Phase of the study may also be eligible to roll over into an extension study.
Source references
references
  1. citation
    Pivonello R, Arnaldi G, Auchus RJ, Badiu C, Busch RS, Cannavo S, Dischinger U, Dobri GA, Donegan DM, Elenkova A, Fazeli PK, Feelders RA, Garcia-Centeno R, Gilis-Januszewska A, Hamidi O, Hannoush ZC, Kargi AY, Miller HJ, Ranetti AE, Recasens M, Reincke M, Rovner S, Salvatori R, Silverstein J, Stigliano A, Terzolo M, Wang C, Yuen KCJ, Kesner-Hays A, Hand AL, Tudor IC, Araque KA, Moraitis AG; GRACE Study Investigators. Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study. Lancet Diabetes Endocrinol. 2026 Apr;14(4):291-304. doi: 10.1016/S2213-8587(25)00362-6. Epub 2026 Feb 20.
    pmid
    41730814
    type
    DERIVED
  2. 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.
    pmid
    35058882
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice