A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

NCT04308590 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CORT125134-456
• Study Type: interventional
• Target: 137
• Locations: 9 countries
• Sites: 45

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 (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

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

Outcome Measures

Primary Outcomes (2)

• Change in Average 24-hour SBP

  Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.

  Baseline and Week 22

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

  Baseline and up to Week 26

Secondary Outcomes (15)

• Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)

  Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22

• Change in Average Diastolic Blood Pressure (DBP)

  Baseline and Week 22

• Change in Average Heart Rate (HR)

  Baseline and Week 22

• Change in Average Daytime and Nighttime SBP

  Baseline and Week 22

• Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline

  Baseline and Week 22

Study Arms (2)

Relacorilant

EXPERIMENTAL

Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.

Drug: Relacorilant; Other: Placebo

Placebo

PLACEBO COMPARATOR

Patients will receive placebo matched to study drug once daily.

Other: Placebo

Interventions

Relacorilant DRUG

Relacorilant is supplied as blister-packed capsules for oral dosing. Relacorilant 400 mg dose consists of 4 relacorilant 100-mg capsules. Relacorilant 100-mg, 200-mg, and 300-mg doses are each given as a combination of 4 capsules containing relacorilant 100-mg and placebo as per the assigned dose.

Also known as: CORT125134

Relacorilant

Placebo OTHER

Placebo is supplied as blister-packed capsules for oral dosing. Each dose consists of 4 capsules containing placebo.

Placebo; Relacorilant

Eligibility Criteria

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

You may qualify if:

• Shows lack of cortisol suppression on dexamethasone suppression test
• Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
• A radiologically confirmed adrenal lesion
• Has IGT or DM
• Has uncontrolled HTN

You may not qualify if:

• Has severe, uncontrolled HTN
• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (45)

Site 27

Birmingham, Alabama, 35294, United States

Location

Site 17

Stanford, California, 94305, United States

Location

Site 53

Torrance, California, 90502, United States

Location

Site 07

Atlanta, Georgia, 30318, United States

Location

Site 16

Indianapolis, Indiana, 46202, United States

Location

Site 09

Metairie, Louisiana, 70006, United States

Location

Site 36

Baltimore, Maryland, 21287, United States

Location

Site 11

Fall River, Massachusetts, 02721, United States

Location

Site 33

Rochester, Minnesota, 55905, United States

Location

Site 06

Jackson, Mississippi, 39202, United States

Location

Site 54

Reno, Nevada, 89511, United States

Location

Site 10

Jamaica, New York, 11432, United States

Location

Site 44

New York, New York, 10021, United States

Location

Site 01

Wilmington, North Carolina, 28401, United States

Location

Site 30

Cleveland, Ohio, 44195, United States

Location

Site 21

Columbus, Ohio, 43201-3209, United States

Location

Site 02

Summerville, South Carolina, 29485, United States

Location

Site 20

Dallas, Texas, 75390, United States

Location

Site 03

El Paso, Texas, 79935, United States

Location

Site 05

Fort Worth, Texas, 76132, United States

Location

Site 08

Houston, Texas, 77079, United States

Location

Site 15

Spokane, Washington, 99202, United States

Location

Site 25

Vienna, Vienna, 1090, Austria

Location

Site 22

Sofia, 01431, Bulgaria

Location

Site 50

Munich, Bavaria, 80336, Germany

Location

Site 46

Würzburg, 97080, Germany

Location

Site 32

Ramat Gan, 5265601, Israel

Location

Site 23

Tel Aviv, Israel

Location

Site 40

Milan, Milano, 20122, Italy

Location

Site 31

Rome, Roma, 00189, Italy

Location

Site 43

Orbassano, Torino, Italy

Location

Site 34

Milan, Italy

Location

Site 28

Napoli, 80131, Italy

Location

Site 51

Padua, 35128, Italy

Location

Site 37

Rome, 00161, Italy

Location

Site 52

Torino, 10126, Italy

Location

Site 48

Gliwice, 44-102, Poland

Location

Site 47

Krakow, 31-501, Poland

Location

Site 35

Lublin, Poland

Location

Site 42

Bucharest, 010825, Romania

Location

Site 38

Bucharest, 011863, Romania

Location

Site 41

Bucharest, 011863, Romania

Location

Site 14

Málaga, 29006, Spain

Location

Site 13

Seville, 41013, Spain

Location

Site 26

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Cushing Syndrome; ACTH Syndrome, Ectopic; Diabetes Mellitus, Type 2; Hypertension

Interventions

relacorilant

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics

info@corcept.com

650-327-3270

Study Officials

• Andreas 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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 16, 2020
• Study Start: July 27, 2020
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: September 4, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (22); BU (1); IL (2); PL (3); ES (3); IT (8); RO (3); DE (2)