Relacorilant for Type 2 Diabetes

Not yet recruiting at 1 trial location
RD
EF
Overseen ByEugene Feigin, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RD

Ralph DeFronzo, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for people with type 2 diabetes that is hard to control, who also have high cortisol levels (a stress hormone). Participants should not have other serious health issues that would make it unsafe to join.

Inclusion Criteria

Negative Glutamic Acid Decarboxylase (GAD) antibody
HbA1c between 7.5% and 10.5%
Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m²
See 10 more

Exclusion Criteria

Night shift workers unless able to temporarily change sleep schedule to complete dexamethasone test
Presence of severe acute medical, psychiatric, or surgical illness
Excessive alcohol intake: >14 drinks/week for men or >7 drinks/week for women
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Relacorilant

Trial Overview

The study tests Relacorilant, an investigational drug, to see if it can help lower blood sugar in people with poorly controlled type 2 diabetes and excess cortisol. The main goal is to check how well the drug works and how safe it is.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study Investigational Drug GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Corcept Therapeutics

Industry Sponsor

Trials
72
Recruited
7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD