Relacorilant in Patients With Poorly Controlled Type 2 Diabetes and Autonomous Cortisol Secretion

November 3, 2026 updated by: The University of Texas Health Science Center at San Antonio

The purpose of this study is to assess the effect and effectiveness of Relacorilant on improving the glucose levels in the blood, thus potentially improving glucose control in patients with hard to control diabetes.

This study involves the use of an investigational drug called Relacorilant. "Investigational" means that the drug has not yet been approved by the U.S. Food & Drug Administration (FDA) for treating "mild hypercortisolism" in patients with diabetes. Cortisol is a "stress hormone". The excess production of cortisol can rise blood sugar (glucose) levels and worsen diabetes. Those disturbances might be corrected by the study medication Relacorilant to improve the state of your diabetes.

This study will evaluate the effects of Relacorilant on glucose control and its safety profile. Although the safety of this drug has been tested in prior human research studies, some side effects may not yet be known.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the study is to investigate the mechanisms by which glucocorticoid receptor (GR) antagonism with relacorilant improves glucose homeostasis in patients with difficult-to-control type 2 diabetes (T2D) and confirmed endogenous hypercortisolism.

Each patient serves as their own control to assess the mechanistic nature of the study. Comparisons made between pre- and post-treatment outcomes. This within-subject design allows detailed assessment of metabolic changes in response to treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Contact:
      • San Antonio, Texas, United States, 78229-3900
        • Texas Diabetes Institute/UH
        • Contact:
        • Principal Investigator:
          • Ralph DeFronzo, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 and 75 years.

  2. Males or females

  3. HbA1c between 7.5% and 10.5%

  4. Type 2 diabetes with at least one of the following:

    • Taking ≥ 3 glucose-lowering drugs
    • Taking 2 glucose lowering medication and 2 anti-hypertensive drugs.
    • Taking insulin and any other glucose lowering drugs
    • Taking ≥ 2 glucose-lowering drugs and presence of microvascular (retinopathy, nephropathy, neuropathy) or ≥ macrovascular (heart attack, heart failure, peripheral vascular disease, atrial fibrillation) disease

  5. No changes in diabetes medications in the 4 weeks prior to enrollment.

  6. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².

  7. Blood pressure lower than 170/110 mmHg.

  8. Abnormal dexamethasone suppression test: morning plasma cortisol >1.8 µg/dL with plasma dexamethasone ≥140 ng/dL.

  9. Self-reported stable (within ±6 lbs in the last 3 months) body weight and body mass index (BMI) between 25-40 kg/m².

  10. Negative Glutamic Acid Decarboxylase (GAD) antibody.

  11. Hematocrit ≥ 34%.

  12. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3× the upper limit of normal.

  13. Female participants of childbearing potential must have a negative pregnancy test and agree to use appropriate contraception throughout the study. (Women who are using hormonal contraceptives will need to agree to use an acceptable method of non-hormonal contraception throughout the study and for ≥6 half-lives after the last dose of assigned treatment (7 days prior to randomization).

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes
  2. New-onset diabetes of less than 1 year duration.
  3. Presence of severe acute medical, psychiatric, or surgical illness.
  4. Use of systemic (oral, IV, intra-articular, or inhaled) or topical glucocorticoids within the past 3 months.
  5. Use of systemic glucocorticoid during the study is prohibited except in the event of medical emergency OR Requires inhaled glucocorticoid use and may require systemic glucocorticoids if their condition deteriorates during the study
  6. Night shift workers (unless able to temporarily change sleep schedule to complete dexamethasone test).
  7. Severe untreated sleep apnea. (Severe untreated sleep apnea, defined as an Apnea-Hypopnea Index (AHI) ≥ 30 events per hour on polysomnography, or a documented clinical diagnosis of severe sleep apnea in patients who are not receiving effective therapy (e.g., CPAP, BiPAP, oral appliance, or surgical treatment).
  8. Excessive alcohol intake: >14 drinks/week for men or >7 drinks/week for women.
  9. Diagnosed with or having treatment plans for Cushing syndrome
  10. Known hypersensitivity to dexamethasone or relacorilant.
  11. Severe, uncontrolled hypertension (>170/110 mmHg) at screening.
  12. Use of another investigational drug within 4 weeks or less than 5 half-lives of the compound, whichever is longer.
  13. Pregnant or lactating women or women of childbearing potential (including all women <50 years old, women whose surgical sterilization was performed <6 months ag; and women who have had a menstrual period in the last 12 months; and women who have a positive pregnancy test before dexamethasone administration.)
  14. Women with a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma.
  15. Diagnosed with or having treatment plans for Cushing syndrome using any of the following treatments: mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, pasireotide, long-acting octreotide or pasireotide.
  16. Uncontrolled thyroid disease (hypo- or hyperthyroidism) prior to first dose of relacorilant as confirmed by TSH outside of normal range (0.4 to 5.0 mIU/L).
  17. Has plans for adrenalectomy or adrenal nodulectomy during the study period.
  18. Taking any co-medications that is disallowed with strong CYP3A inhibitors and cannot undergo dose modifications on coadministration with a strong CYP3A inhibitor
  19. Ongoing use of any strong CYP3A4 inducer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Investigational Drug Group

Participants will receive study intervention once daily after screening and dexamethasone suppression test.
Drug: Relacorilant

A capsule that will be given once daily starting at 100mg and increasing gradually to 400mg once a day.

Other Names:
  • CORT125134

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c (measure of average blood sugar over 3 months) levels
Time Frame: Baseline to 24 weeks

Lab test performed on whole blood hemoglobin to determine the blood sugar level over a 3 month period
Baseline to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Beta-cell funtion
Time Frame: Baseline to 24 weeks

Disposition index and C-peptide response during OGTT and euglycemic insulin clamp.
Baseline to 24 weeks
Change in total body fat
Time Frame: Baseline to 24 weeks

Measured by DEXA scan
Baseline to 24 weeks
Liver and visceral fat
Time Frame: Baseline to 24 weeks

Measured using MRI PDFF (magnetic resonance imaging-proton density fat fraction)
Baseline to 24 weeks
Liver stiffness
Time Frame: Baseline to 24 weeks

Assessed using Fibroscan
Baseline to 24 weeks
Change in insulin sensitivity
Time Frame: Baseline to 20-24 weeks

Assessed using the Oral glucose tolerance test
Baseline to 20-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Corcept Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ralph DeFronzo, MD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the Diabetes division at UT Health. This will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number.

IPD Sharing Time Frame

After study completion and data analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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