Trial Outcomes & Findings for A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (NCT NCT04308590)
NCT ID: NCT04308590
Last Updated: 2025-09-04
Results Overview
Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
COMPLETED
PHASE3
137 participants
Baseline and Week 22
2025-09-04
Participant Flow
A total of 307 patients were screened and 137 were enrolled.
Participant milestones
| Measure |
Relacorilant
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
69
|
|
Overall Study
COMPLETED
|
43
|
61
|
|
Overall Study
NOT COMPLETED
|
25
|
8
|
Reasons for withdrawal
| Measure |
Relacorilant
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Subject does not want to continue with Pi
|
0
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Baseline characteristics by cohort
| Measure |
Relacorilant
n=68 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=69 Participants
Patients will receive placebo matched to study drug once daily.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 9.00 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hypertension (HTN) only
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Diabetes mellitus (DM) or impaired glucose tolerance (IGT) only
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
HTN and DM/IGT
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline.
Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported.
Outcome measures
| Measure |
Relacorilant
n=42 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=42 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Average 24-hour SBP
|
-5.56 mm Hg
Interval -10.459 to -0.659
|
-2.89 mm Hg
Interval -6.794 to 1.006
|
PRIMARY outcome
Timeframe: Baseline and up to Week 26Population: The analysis population was patients in the Safety Population which included all randomized patients who received at least 1 dose of study drug.
Outcome measures
| Measure |
Relacorilant
n=68 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=69 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
|
67 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22Population: 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.
AUCglucose was calculated based on results of the plasma 2-hour oGTT.
Outcome measures
| Measure |
Relacorilant
n=29 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=38 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose)
|
-1.566 hours x mmol/L
Interval -3.472 to 0.34
|
1.008 hours x mmol/L
Interval -0.661 to 2.676
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
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.
Outcome measures
| Measure |
Relacorilant
n=21 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=30 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Average Diastolic Blood Pressure (DBP)
24-hour Average
|
-3.3 mm Hg
Interval -6.1 to -0.5
|
-1.4 mm Hg
Interval -3.8 to 0.9
|
|
Change in Average Diastolic Blood Pressure (DBP)
Daytime Average
|
-3.1 mm Hg
Interval -6.0 to -0.1
|
-1.0 mm Hg
Interval -3.5 to 1.6
|
|
Change in Average Diastolic Blood Pressure (DBP)
Nighttime Average
|
-3.0 mm Hg
Interval -6.4 to 0.5
|
-0.6 mm Hg
Interval -3.5 to 2.4
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
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.
Outcome measures
| Measure |
Relacorilant
n=21 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=30 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Average Heart Rate (HR)
24-hour Average
|
2.0 Beats per minute
Interval -0.4 to 4.5
|
-2.0 Beats per minute
Interval -4.1 to 0.1
|
|
Change in Average Heart Rate (HR)
Daytime Average
|
1.7 Beats per minute
Interval -1.1 to 4.5
|
-1.5 Beats per minute
Interval -3.9 to 0.9
|
|
Change in Average Heart Rate (HR)
Nighttime Average
|
2.2 Beats per minute
Interval -0.4 to 4.7
|
-2.7 Beats per minute
Interval -4.9 to -0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
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.
Outcome measures
| Measure |
Relacorilant
n=21 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=30 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Average Daytime and Nighttime SBP
Daytime Average
|
-4.5 mm Hg
Interval -9.0 to -0.1
|
-2.5 mm Hg
Interval -6.3 to 1.4
|
|
Change in Average Daytime and Nighttime SBP
Nighttime Average
|
-4.6 mm Hg
Interval -9.9 to 0.6
|
-3.0 mm Hg
Interval -7.5 to 1.4
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=25 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=36 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline
|
-0.29 Percentage
Interval -0.49 to -0.09
|
0.00 Percentage
Interval -0.17 to 0.17
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=11 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=17 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline
|
-0.57 Percentage
Interval -1.0 to -0.14
|
-0.19 Percentage
Interval -0.52 to 0.14
|
SECONDARY outcome
Timeframe: 2 hours post glucose drink at Week 22Population: 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.
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Outcome measures
| Measure |
Relacorilant
n=27 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=28 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours post glucose drink at Week 22Population: 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.
Glucose was measured using the 2 hour timepoint of the 2-hour oGTT.
Outcome measures
| Measure |
Relacorilant
n=18 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=16 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=22 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=33 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With Any Dose Decrease in Antihypertensive Medication
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=15 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=25 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With Any Dose Decrease in Diabetes Medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=22 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=33 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=15 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=25 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With Any Dose Increase or Switch in Diabetes Medication
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: 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.
Outcome measures
| Measure |
Relacorilant
n=18 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=21 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5%
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline.
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.
Outcome measures
| Measure |
Relacorilant
n=42 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=42 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg)
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 22Population: The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline.
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.
Outcome measures
| Measure |
Relacorilant
n=42 Participants
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=42 Participants
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg
|
10 Participants
|
13 Participants
|
Adverse Events
Relacorilant
Placebo
Serious adverse events
| Measure |
Relacorilant
n=68 participants at risk
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=69 participants at risk
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
2/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.9%
2/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Cardiac disorders
Acute coronary syndrome
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Cardiac disorders
Coronary artery stenosis
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Investigations
Hepatic enzyme increased
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Infections and infestations
Localised infection
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Nervous system disorders
Presyncope
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.5%
1/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
Other adverse events
| Measure |
Relacorilant
n=68 participants at risk
Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily.
|
Placebo
n=69 participants at risk
Patients will receive placebo matched to study drug once daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.6%
14/68 • Up to Week 26
|
4.3%
3/69 • Up to Week 26
|
|
Gastrointestinal disorders
Nausea
|
19.1%
13/68 • Up to Week 26
|
11.6%
8/69 • Up to Week 26
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
12/68 • Up to Week 26
|
2.9%
2/69 • Up to Week 26
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
9/68 • Up to Week 26
|
8.7%
6/69 • Up to Week 26
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
6/68 • Up to Week 26
|
2.9%
2/69 • Up to Week 26
|
|
Gastrointestinal disorders
Constipation
|
5.9%
4/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
4/68 • Up to Week 26
|
2.9%
2/69 • Up to Week 26
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.4%
3/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.9%
21/68 • Up to Week 26
|
13.0%
9/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.1%
13/68 • Up to Week 26
|
7.2%
5/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
8/68 • Up to Week 26
|
20.3%
14/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
7/68 • Up to Week 26
|
4.3%
3/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
7/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
2/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.5%
1/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
General disorders
Fatigue
|
23.5%
16/68 • Up to Week 26
|
14.5%
10/69 • Up to Week 26
|
|
General disorders
Asthenia
|
11.8%
8/68 • Up to Week 26
|
8.7%
6/69 • Up to Week 26
|
|
General disorders
Oedema peripheral
|
8.8%
6/68 • Up to Week 26
|
7.2%
5/69 • Up to Week 26
|
|
Nervous system disorders
Dizziness
|
14.7%
10/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
Nervous system disorders
Headache
|
10.3%
7/68 • Up to Week 26
|
17.4%
12/69 • Up to Week 26
|
|
Nervous system disorders
Sciatica
|
7.4%
5/68 • Up to Week 26
|
1.4%
1/69 • Up to Week 26
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
4/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.4%
5/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
5/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
4/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Infections and infestations
COVID-19
|
5.9%
4/68 • Up to Week 26
|
13.0%
9/69 • Up to Week 26
|
|
Infections and infestations
Urinary tract infection
|
5.9%
4/68 • Up to Week 26
|
2.9%
2/69 • Up to Week 26
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
8/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
5/68 • Up to Week 26
|
4.3%
3/69 • Up to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
5/68 • Up to Week 26
|
2.9%
2/69 • Up to Week 26
|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
5/68 • Up to Week 26
|
0.00%
0/69 • Up to Week 26
|
|
Vascular disorders
Hypertension
|
4.4%
3/68 • Up to Week 26
|
13.0%
9/69 • Up to Week 26
|
|
Psychiatric disorders
Insomnia
|
8.8%
6/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/68 • Up to Week 26
|
5.8%
4/69 • Up to Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual publications will be allowed before publication of the multicenter results, except as agreed with Corcept. The Investigator agrees to submit all manuscripts or abstracts to Corcept for review before submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER