This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
96
Olanzapine 10 mg oral tablet
CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Mean Change from Baseline in Body Weight
Time frame: Pre-dose on Day 1 (Baseline) and Day 15
Percentage of Participants with One or More Adverse Events
Time frame: Up to Day 28
Percentage of Participants with One or More Serious Adverse Events
Time frame: Up to Day 28
Percentage of Participants Discontinued from the Study due to an Adverse Event
Time frame: Up to Day 28
Mean Change from Baseline in Glucose
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Insulin
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Triglycerides
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Waist-to-Hip Ratio
Time frame: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28
Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
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Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7