Trial Outcomes & Findings for A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications (NCT NCT03818256)
NCT ID: NCT03818256
Last Updated: 2024-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Baseline Day 1 and Week 12
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Miricorilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Miricorilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Gaining weight without prohibited medication vyvanse
|
1
|
0
|
|
Overall Study
Not reporting for scheduled visits
|
1
|
0
|
|
Overall Study
Non-compliant with investigational product
|
1
|
0
|
Baseline Characteristics
Two patients in the placebo group did not have a Baseline HOMA-IR measurement.
Baseline characteristics by cohort
| Measure |
Miricorilant 600 mg
n=35 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 10.50 • n=35 Participants
|
47.5 Years
STANDARD_DEVIATION 11.78 • n=36 Participants
|
45.7 Years
STANDARD_DEVIATION 11.24 • n=71 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=35 Participants
|
20 Participants
n=36 Participants
|
39 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=35 Participants
|
16 Participants
n=36 Participants
|
32 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=35 Participants
|
9 Participants
n=36 Participants
|
16 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=35 Participants
|
27 Participants
n=36 Participants
|
55 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=35 Participants
|
16 Participants
n=36 Participants
|
29 Participants
n=71 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=35 Participants
|
20 Participants
n=36 Participants
|
41 Participants
n=71 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
36 participants
n=36 Participants
|
71 participants
n=71 Participants
|
|
Body weight
|
110.39 kg
STANDARD_DEVIATION 20.01 • n=35 Participants
|
107.69 kg
STANDARD_DEVIATION 25.41 • n=36 Participants
|
109.02 kg
STANDARD_DEVIATION 22.79 • n=71 Participants
|
|
Homeostatic model assessment for insulin resistance (HOMA-IR)
|
8.687 HOMA-IR score
STANDARD_DEVIATION 5.71 • n=35 Participants • Two patients in the placebo group did not have a Baseline HOMA-IR measurement.
|
8.463 HOMA-IR score
STANDARD_DEVIATION 17.27 • n=34 Participants • Two patients in the placebo group did not have a Baseline HOMA-IR measurement.
|
8.577 HOMA-IR score
STANDARD_DEVIATION 13.24 • n=69 Participants • Two patients in the placebo group did not have a Baseline HOMA-IR measurement.
|
|
Waist-to-hip ratio
|
1.032 Ratio
STANDARD_DEVIATION 0.24 • n=35 Participants
|
0.967 Ratio
STANDARD_DEVIATION 0.10 • n=36 Participants
|
0.999 Ratio
STANDARD_DEVIATION 0.18 • n=71 Participants
|
PRIMARY outcome
Timeframe: Baseline Day 1 and Week 12Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight assessed at Baseline and on Week 12.
Outcome measures
| Measure |
Miricorilant 600 mg
n=29 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=29 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
|
-0.98 kg
Standard Error 0.414
|
-1.08 kg
Standard Error 0.415
|
PRIMARY outcome
Timeframe: Up to Follow-up Visit (Week 16)Population: The Safety Population included patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorilant 600 mg
n=35 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Number of Patients With One or More Treatment-emergent Adverse Events
|
16 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Up to Follow-up Visit (up to Week 16)Population: The Safety Population included patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorilant 600 mg
n=35 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Number of Patients With One or More Treatment-emergent Serious Adverse Events
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Follow-up Visit (up to Week 16)Population: The Safety Population included patients who received ≥1 dose of study drug.
Outcome measures
| Measure |
Miricorilant 600 mg
n=35 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline Day 1 to Week 12Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had baseline and ≥1 body weight measurement taken on or after Week 4.
Outcome measures
| Measure |
Miricorilant 600 mg
n=33 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=33 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Percentage of Patients Achieving More Than or Equal to 5% Weight Loss
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline Day 1 and Week 12Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had HOMA-IR assessed at Baseline and on Week 12.
HOMA-IR = \[fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score \>1.9 indicates early insulin resistance and a score \>2.9 indicates significant insulin resistance.
Outcome measures
| Measure |
Miricorilant 600 mg
n=26 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=23 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Change From Baseline in HOMA-IR at Week 12
|
1.080 HOMA-IR score
Interval -2.02 to 3.78
|
0.890 HOMA-IR score
Interval -0.97 to 2.4
|
SECONDARY outcome
Timeframe: Baseline Day 1 and Week 12Population: The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had hip and waist measurements at Baseline and on Week 12.
Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio \<0.95 in men and \<0.80 in women is considered healthy.
Outcome measures
| Measure |
Miricorilant 600 mg
n=29 Participants
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=29 Participants
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Change From Baseline in Waist-to-hip Ratio at Week 12
|
0.008 Ratio
Standard Error 0.0092
|
0.001 Ratio
Standard Error 0.0091
|
Adverse Events
Miricorilant 600 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Miricorilant 600 mg
n=35 participants at risk
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 participants at risk
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
General disorders
Hyperthermia malignant
|
2.9%
1/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
2.9%
1/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Psychiatric disorders
Mania
|
0.00%
0/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
2.8%
1/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
Other adverse events
| Measure |
Miricorilant 600 mg
n=35 participants at risk
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Miricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
|
Placebo
n=36 participants at risk
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Placebo: Placebo tablets for once daily oral dosing
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
5.6%
2/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
5/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
4/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
5.6%
2/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
3/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
2.8%
1/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Nervous system disorders
Akathisia
|
5.7%
2/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
5.6%
2/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
5.7%
2/35 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
0.00%
0/36 • Baseline Day 1 to Week 16
The Safety Population included patients who received ≥1 dose of study drug.
|
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