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

Last updated: August 15, 2025
Sponsor: Corcept Therapeutics
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Vascular Diseases

Stress

Treatment

relacorilant

Relacorilant

Placebo

Clinical Study ID

NCT04308590
CORT125134-456
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 137
Treatment Group(s): 3
Primary Treatment: relacorilant
Phase: 3
Study Start date:
July 27, 2020
Estimated Completion Date:
September 19, 2024

Study Description

The primary outcome measures of the study are 1) to assess the efficacy of relacorilant based on blood pressure control at Week 22 compared with placebo, and 2) to assess the safety of relacorilant based on adverse events. 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.

Connect with a study center

  • Site 49

    Graz, Styria 8036
    Austria

    Site Not Available

  • Site 25

    Wien, Vienna 1090
    Austria

    Site Not Available

  • Site 25

    Vienna 2761369, Vienna 2761367 1090
    Austria

    Site Not Available

  • Site 22

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Site 22

    Sofia 727011, 01431
    Bulgaria

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  • Site 50

    Munich, Bavaria 80336
    Germany

    Site Not Available

  • Site 50

    Munich 2867714, Bavaria 2951839 80336
    Germany

    Site Not Available

  • Site 46

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Site 46

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • Site 24

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Site 18

    Petach Tikva, 4941480
    Israel

    Site Not Available

  • Site 32

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Site 32

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Site 23

    Tel Aviv,
    Israel

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  • Site 23

    Tel Aviv 293397,
    Israel

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  • Site 40

    Milan, Milano 20122
    Italy

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  • Site 40

    Milan 3173435, Milano 20122
    Italy

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  • Site 31

    Rome, Roma 00189
    Italy

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  • Site 31

    Rome 3169070, Roma 00189
    Italy

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  • Site 43

    Orbassano, Torino
    Italy

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  • Site 43

    Orbassano 3171986, Torino
    Italy

    Site Not Available

  • Site 34

    Milan,
    Italy

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  • Site 34

    Milan 3173435,
    Italy

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  • Site 28

    Napoli, 80131
    Italy

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  • Site 28

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Site 51

    Padova, 35128
    Italy

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  • Site 51

    Padua 3171728, 35128
    Italy

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  • Site 37

    Rome, 00161
    Italy

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  • Site 37

    Rome 3169070, 00161
    Italy

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  • Site 52

    Torino, 10126
    Italy

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  • Site 52

    Torino 8980539, 10126
    Italy

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  • Site 48

    Gliwice, 44-102
    Poland

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  • Site 48

    Gliwice 3099230, 44-102
    Poland

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  • Site 47

    Krakow, 31-501
    Poland

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  • Site 47

    Krakow 3094802, 31-501
    Poland

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  • Site 35

    Lublin,
    Poland

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  • Site 35

    Lublin 765876,
    Poland

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  • Site 38

    Bucharest, 011863
    Romania

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  • Site 41

    Bucharest, 011863
    Romania

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  • Site 42

    Bucharest, 010825
    Romania

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  • Site 38

    Bucharest 683506, 011863
    Romania

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  • Site 41

    Bucharest 683506, 011863
    Romania

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  • Site 42

    Bucharest 683506, 010825
    Romania

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  • Site 29

    Girona, 17007
    Spain

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  • Site 14

    Malaga, 29006
    Spain

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  • Site 14

    Málaga 2514256, 29006
    Spain

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  • Site 13

    Sevilla, 41013
    Spain

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  • Site 13

    Seville 2510911, 41013
    Spain

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  • Site 26

    Valencia, 46026
    Spain

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  • Site 26

    Valencia 2509954, 46026
    Spain

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  • Site 27

    Birmingham, Alabama 35294
    United States

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  • Site 27

    Birmingham 4049979, Alabama 4829764 35294
    United States

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  • Site 17

    Stanford, California 94305
    United States

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  • Site 53

    Torrance, California 90502
    United States

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  • Site 17

    Stanford 5398563, California 5332921 94305
    United States

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  • Site 53

    Torrance 5403022, California 5332921 90502
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  • Site 55

    Miami, Florida 33136
    United States

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  • Site 07

    Atlanta, Georgia 30318
    United States

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  • Site 07

    Atlanta 4180439, Georgia 4197000 30318
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  • Site 16

    Indianapolis, Indiana 46202
    United States

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  • Site 16

    Indianapolis 4259418, Indiana 4921868 46202
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  • Site 09

    Metairie, Louisiana 70006
    United States

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  • Site 09

    Metairie 4333177, Louisiana 4331987 70006
    United States

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  • Site 36

    Baltimore, Maryland 21287
    United States

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  • Site 36

    Baltimore 4347778, Maryland 4361885 21287
    United States

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  • Site 11

    Fall River, Massachusetts 02721
    United States

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  • Site 11

    Fall River 4936159, Massachusetts 6254926 02721
    United States

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  • Site 45

    Ann Arbor, Michigan 48109
    United States

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  • Site 33

    Rochester, Minnesota 55905
    United States

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  • Site 33

    Rochester 5043473, Minnesota 5037779 55905
    United States

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  • Site 06

    Jackson, Mississippi 39202
    United States

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  • Site 06

    Jackson 4431410, Mississippi 4436296 39202
    United States

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  • Site 54

    Reno, Nevada 89511
    United States

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  • Site 54

    Reno 5511077, Nevada 5509151 89511
    United States

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  • Site 19

    Albany, New York 12206
    United States

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  • Site 10

    Jamaica, New York 11432
    United States

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  • Site 44

    New York, New York 10021
    United States

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  • Site 10

    Jamaica 5122520, New York 5128638 11432
    United States

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  • Site 44

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Site 01

    Wilmington, North Carolina 28401
    United States

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  • Site 01

    Wilmington 4499379, North Carolina 4482348 28401
    United States

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  • Site 30

    Cleveland, Ohio 44195
    United States

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  • Site 21

    Columbus, Ohio 43201-3209
    United States

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  • Site 30

    Cleveland 5150529, Ohio 5165418 44195
    United States

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  • Site 21

    Columbus 4509177, Ohio 5165418 43201-3209
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  • Site 39

    Philadelphia, Pennsylvania 19107
    United States

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  • Site 12

    Pittsburgh, Pennsylvania 15202
    United States

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  • Site 02

    Summerville, South Carolina 29485
    United States

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  • Site 07

    Summerville, South Carolina 29485
    United States

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  • Site 02

    Summerville 4597919, South Carolina 4597040 29485
    United States

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  • Site 20

    Dallas, Texas 75390
    United States

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  • Site 03

    El Paso, Texas 79935
    United States

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  • Site 05

    Fort Worth, Texas 76132
    United States

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  • Site 08

    Houston, Texas 77079
    United States

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  • Site 04

    Shavano Park, Texas 78231
    United States

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  • Site 20

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Site 03

    El Paso 5520993, Texas 4736286 79935
    United States

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  • Site 05

    Fort Worth 4691930, Texas 4736286 76132
    United States

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  • Site 08

    Houston 4699066, Texas 4736286 77079
    United States

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  • Site 15

    Spokane, Washington 99202
    United States

    Site Not Available

  • Site 15

    Spokane 5811696, Washington 5815135 99202
    United States

    Site Not Available

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