| Primary | Change in Average 24-hour SBP | Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline. | Posted | | Least Squares Mean | 95% Confidence Interval | mm Hg | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-5.56(-10.459 to -0.659)
- OG001-2.89(-6.794 to 1.006)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | 0.4160 | | Least squares mean difference | -2.67 | | | 2-Sided | 95 | -9.096 | 3.766 | | | | | Equivalence | The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication. | |
|
| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | | The analysis population was patients in the Safety Population which included all randomized patients who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline and up to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) | AUCglucose was calculated based on results of the plasma 2-hour oGTT. | The analysis population was patients in the ITT Population who had DM/IGT with or without HTN at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | hours x mmol/L | | Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in Average Diastolic Blood Pressure (DBP) | Blood pressure was measured by 24-hour ABPM. Daytime average DBP was measured from 06:00 to 21:59. Nighttime average DBP was measure from 22:00 to 05:59. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | mm Hg | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in Average Heart Rate (HR) | Heart rate was measured by 24-hour ABPM. Daytime average HR was measured from 06:00 to 21:59. Nighttime average HR was measure from 22:00 to 05:59. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | Beats per minute | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in Average Daytime and Nighttime SBP | Blood pressure was measured by 24-hour ABPM. Daytime average SBP was measured from 06:00 to 21:59. Nighttime average SBP was measure from 22:00 to 05:59. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | mm Hg | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline | | The analysis population was patients in the ITT Population who had DM/IGT with HbA1c ≥5.7% at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline | | The analysis population was patients in the ITT Population who had DM/IGT with HbA1c ≥6.5% at Baseline and had an available assessment at Week 22. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. | The analysis population was patients in the ITT Population who had DM with or without HTN at Baseline and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | 2 hours post glucose drink at Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. | The analysis population was patients in the ITT Population who had IGT with or without HTN at Baseline and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | 2 hours post glucose drink at Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With Any Dose Decrease in Antihypertensive Medication | | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline, received antihypertension medication both at Baseline and postbaseline, and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With Any Dose Decrease in Diabetes Medication | | The analysis population was patients in the ITT Population who had DM/IGT at Baseline, received diabetes medication both at Baseline and postbaseline, and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication | | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline, received antihypertension medication both at Baseline and postbaseline, and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With Any Dose Increase or Switch in Diabetes Medication | | The analysis population was patients in the ITT Population who had DM/IGT at Baseline, received diabetes medication both at Baseline and postbaseline, and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5% | | The analysis population was patients in the ITT Population who had DM with HbA1c ≥6.5% at Baseline and had an available assessment at Week 22. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg) | Blood pressure was measured by 24-hour ABPM Test. Reported is the number of patients with HTN at Baseline who achieved SBP <130 mm Hg at Week 22. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |
| Secondary | Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg | Blood pressure was measured by 24-hour ABPM. Reported is the number of patients with HTN at Baseline who achieved at least a 5 mm Hg reduction in 24-hour average SBP at Week 22. | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline. | Posted | | Count of Participants | | Participants | | Baseline and Week 22 | | | | ID | Title | Description |
|---|
| OG000 | Relacorilant | Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. | | OG001 | Placebo | Patients will receive placebo matched to study drug once daily. |
| |