Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
- Registration Number
- NCT04308590
- Lead Sponsor
- Corcept Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- Shows lack of cortisol suppression
- Suppressed or low early-morning ACTH levels
- A radiologically confirmed adrenal lesion
- Has IGT or DM
- Has uncontrolled hypertension
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relacorilant relacorilant The dose of relacorilant will be increased sequentially from 100 mg orally once daily to a target dose of 400 mg once daily. Placebo Placebo Placebo matched to study drug
- Primary Outcome Measures
Name Time Method 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 Baseline to week 22 Assessment of safety based on TEAEs Baseline to week 22 Assessment of safety based on treatment-emergent adverse events (TEAEs) as graded by CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method Mean change in AUCglucose, from baseline to Week 22 as compared between relacorilant and placebo arms Baseline to Week 22/ET Assessment based on AUCglucose Test
Mean change in average diastolic blood pressure (DBP) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in average heart rate (HR) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in daytime average diastolic blood pressure (DBP) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in daytime average heart rate (HR) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in daytime average systolic blood pressure (SBP) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in HbA1c (HbA1c at Baseline greater than 5.7%) Baseline to Week 22/ET Assessment based on HbA1c Test
Mean change in HbA1c (HbA1c at Baseline greater than 6.5%) Baseline to Week 22/ET Assessment based on HbA1c Test
Mean change in nighttime average diastolic blood pressure (DBP) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in nighttime average heart rate (HR) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Mean change in nighttime average systolic blood pressure (SBP) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Proportion of patients (DM) who achieved 2-hour oGTT glucose less than 140 mg/dL Baseline to Week 22/ET Assessment based on 2-hour oGTT Test
Proportion of patients (IGT) who achieved 2-hour oGTT glucose less than 140 mg/dL Baseline to Week 22/ET Assessment based on 2-hour oGTT Test
Proportion of patients with any dose decrease in antihypertensive medication due to improved blood pressure Baseline to Week 22/ET Proportion of patients with any dose decrease of diabetes medication due to improved glucose control Baseline to Week 22/ET Proportion of patients with any dose increase in antihypertensive medications due to worsening hypertension Baseline to Week 22/ET Proportion of patients with any dose increase of diabetes medication due to worsening hyperglycemia Baseline to Week 22/ET Proportion of patients with HbA1c greater than or equal to 6.5% at Baseline who achieved HbA1c less than 6.5% Baseline to Week 22/ET Assessment based on HbA1c Test
Proportion of patients with normalization of the average SBP (less than 130 mm Hg, based on 24-hour ABPM) Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Proportion of patients with a reduction in 24-hour average SBP by 5 mm Hg Baseline to Week 22/ET Assessment based on 24-hour ABPM Test
Trial Locations
- Locations (45)
Site 21
🇺🇸Columbus, Ohio, United States
Site 27
🇺🇸Birmingham, Alabama, United States
Site 17
🇺🇸Stanford, California, United States
Site 53
🇺🇸Torrance, California, United States
Site 07
🇺🇸Atlanta, Georgia, United States
Site 16
🇺🇸Indianapolis, Indiana, United States
Site 09
🇺🇸Metairie, Louisiana, United States
Site 36
🇺🇸Baltimore, Maryland, United States
Site 11
🇺🇸Fall River, Massachusetts, United States
Site 33
🇺🇸Rochester, Minnesota, United States
Site 06
🇺🇸Jackson, Mississippi, United States
Site 54
🇺🇸Reno, Nevada, United States
Site 10
🇺🇸Jamaica, New York, United States
Site 44
🇺🇸New York, New York, United States
Site 01
🇺🇸Wilmington, North Carolina, United States
Site 30
🇺🇸Cleveland, Ohio, United States
Site 02
🇺🇸Summerville, South Carolina, United States
Site 20
🇺🇸Dallas, Texas, United States
Site 03
🇺🇸El Paso, Texas, United States
Site 05
🇺🇸Fort Worth, Texas, United States
Site 08
🇺🇸Houston, Texas, United States
Site 15
🇺🇸Spokane, Washington, United States
Site 25
🇦🇹Wien, Vienna, Austria
Site 22
🇧🇬Sofia, Bulgaria
Site 50
🇩🇪Munich, Bavaria, Germany
Site 46
🇩🇪Wuerzburg, Germany
Site 32
🇮🇱Ramat Gan, Israel
Site 23
🇮🇱Tel Aviv, Israel
Site 40
🇮🇹Milan, Milano, Italy
Site 31
🇮🇹Rome, Roma, Italy
Site 43
🇮🇹Orbassano, Torino, Italy
Site 34
🇮🇹Milan, Italy
Site 28
🇮🇹Napoli, Italy
Site 51
🇮🇹Padova, Italy
Site 37
🇮🇹Rome, Italy
Site 52
🇮🇹Torino, Italy
Site 48
🇵🇱Gliwice, Poland
Site 47
🇵🇱Krakow, Poland
Site 35
🇵🇱Lublin, Poland
Site 42
🇷🇴Bucharest, Romania
Site 38
🇷🇴Bucharest, Romania
Site 41
🇷🇴Bucharest, Romania
Site 14
🇪🇸Malaga, Spain
Site 13
🇪🇸Sevilla, Spain
Site 26
🇪🇸Valencia, Spain