Clinical trial NCT04308590: Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Official title: Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercortisolism
Keywords: Cushing syndrome
Cushing
Hypercortisolemia
Type 2 Diabetes
Impaired Glucose Intolerance
Hypertension
Adrenocorticotropic hormone
Primary Pigmented Nodular Adrenal Disease
Macronodular adrenal hyperplasia
Adrenal Adenoma
Adrenal Autonomy
Cortisol
Autonomous cortisol secretion
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance and/or uncontrolled systolic hypertension.

Detailed description: This Phase 3 study patients will be randomized in a 1:1 ratio to treatment with relacorilant (active drug) or placebo. Patients will receive relacorilant or placebo for 22 weeks. Patients who complete the study may also be eligible to roll over into an extension study.

Eligibility criteria: Inclusion Criteria:

* Shows lack of cortisol suppression
* Suppressed or low early-morning ACTH levels
* A radiologically confirmed adrenal lesion
* Has IGT or DM
* Has uncontrolled hypertension

Exclusion Criteria:

* Has severe, uncontrolled hypertension
* Has poorly controlled DM
* Has DM Type 1
* Has significantly abnormal liver test results or severe renal insufficiency
* Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism

Primary outcomes:
measure: The mean change in average systolic blood pressure (SBP) based on 24-hour ambulatory blood pressure monitoring (ABPM), from Baseline to Week 22 as compared between relacorilant and placebo arms
timeFrame: Baseline to week 22
measure: Assessment of safety based on TEAEs
timeFrame: Baseline to week 22
Secondary outcomes:
measure: Mean change in AUCglucose, from baseline to Week 22 as compared between relacorilant and placebo arms
timeFrame: Baseline to Week 22/ET
measure: Mean change in average diastolic blood pressure (DBP)
timeFrame: Baseline to Week 22/ET
measure: Mean change in average heart rate (HR)
timeFrame: Baseline to Week 22/ET
measure: Mean change in daytime average diastolic blood pressure (DBP)
timeFrame: Baseline to Week 22/ET
measure: Mean change in daytime average heart rate (HR)
timeFrame: Baseline to Week 22/ET
measure: Mean change in daytime average systolic blood pressure (SBP)
timeFrame: Baseline to Week 22/ET
measure: Mean change in HbA1c (HbA1c at Baseline greater than 5.7%)
timeFrame: Baseline to Week 22/ET
measure: Mean change in HbA1c (HbA1c at Baseline greater than 6.5%)
timeFrame: Baseline to Week 22/ET
measure: Mean change in nighttime average diastolic blood pressure (DBP)
timeFrame: Baseline to Week 22/ET
measure: Mean change in nighttime average heart rate (HR)
timeFrame: Baseline to Week 22/ET
measure: Mean change in nighttime average systolic blood pressure (SBP)
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients (DM) who achieved 2-hour oGTT glucose less than 140 mg/dL
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients (IGT) who achieved 2-hour oGTT glucose less than 140 mg/dL
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with any dose decrease in antihypertensive medication due to improved blood pressure
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with any dose decrease of diabetes medication due to improved glucose control
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with any dose increase in antihypertensive medications due to worsening hypertension
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with any dose increase of diabetes medication due to worsening hyperglycemia
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with HbA1c greater than or equal to 6.5% at Baseline who achieved HbA1c less than 6.5%
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with normalization of the average SBP (less than 130 mm Hg, based on 24-hour ABPM)
timeFrame: Baseline to Week 22/ET
measure: Proportion of patients with a reduction in 24-hour average SBP by 5 mm Hg
timeFrame: Baseline to Week 22/ET
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 27
state: Alabama
city: Stanford
country: United States
facility: Site 17
state: California
city: Torrance
country: United States
facility: Site 53
state: California
city: Atlanta
country: United States
facility: Site 07
state: Georgia
city: Indianapolis
country: United States
facility: Site 16
state: Indiana
city: Metairie
country: United States
facility: Site 09
state: Louisiana
city: Baltimore
country: United States
facility: Site 36
state: Maryland
city: Fall River
country: United States
facility: Site 11
state: Massachusetts
city: Rochester
country: United States
facility: Site 33
state: Minnesota
city: Jackson
country: United States
facility: Site 06
state: Mississippi
city: Reno
country: United States
facility: Site 54
state: Nevada
city: Jamaica
country: United States
facility: Site 10
state: New York
city: New York
country: United States
facility: Site 44
state: New York
city: Wilmington
country: United States
facility: Site 01
state: North Carolina
city: Cleveland
country: United States
facility: Site 30
state: Ohio
city: Columbus
country: United States
facility: Site 21
state: Ohio
city: Summerville
country: United States
facility: Site 02
state: South Carolina
city: Dallas
country: United States
facility: Site 20
state: Texas
city: El Paso
country: United States
facility: Site 03
state: Texas
city: Fort Worth
country: United States
facility: Site 05
state: Texas
city: Houston
country: United States
facility: Site 08
state: Texas
city: Spokane
country: United States
facility: Site 15
state: Washington
city: Wien
country: Austria
facility: Site 25
state: Vienna
city: Sofia
country: Bulgaria
facility: Site 22
city: Munich
country: Germany
facility: Site 50
state: Bavaria
city: Wuerzburg
country: Germany
facility: Site 46
city: Ramat Gan
country: Israel
facility: Site 32
city: Tel Aviv
country: Israel
facility: Site 23
city: Milan
country: Italy
facility: Site 40
state: Milano
city: Rome
country: Italy
facility: Site 31
state: Roma
city: Orbassano
country: Italy
facility: Site 43
state: Torino
city: Milan
country: Italy
facility: Site 34
city: Napoli
country: Italy
facility: Site 28
city: Padova
country: Italy
facility: Site 51
city: Rome
country: Italy
facility: Site 37
city: Torino
country: Italy
facility: Site 52
city: Gliwice
country: Poland
facility: Site 48
city: Krakow
country: Poland
facility: Site 47
city: Lublin
country: Poland
facility: Site 35
city: Bucharest
country: Romania
facility: Site 42
city: Bucharest
country: Romania
facility: Site 38
city: Bucharest
country: Romania
facility: Site 41
city: Malaga
country: Spain
facility: Site 14
city: Sevilla
country: Spain
facility: Site 13
city: Valencia
country: Spain
facility: Site 26
Study officials:
affiliation: Corcept Therapeutics
name: Andreas Moraitis, MD
role: STUDY_DIRECTOR
References: