The Effect of CORT118335 on Olanzapine-Induced Weight Gain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Antipsychotic-induced Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Olanzapine plus CORT118335

Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

Olanzapine 10 mg oral tablet

CORT118335

Intervention Type DRUG

CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets

Olanzapine plus Placebo

Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days.

Group Type PLACEBO_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine 10 mg oral tablet

Placebo

Intervention Type DRUG

Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available

Interventions

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Olanzapine

Olanzapine 10 mg oral tablet

Intervention Type DRUG

CORT118335

CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets

Intervention Type DRUG

Placebo

Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index 18.0 to 25.0 kg/m\^2, inclusive
* Stable body weight as indicated by assessment at screening and pre-dose
* Able to swallow the size and number of tablets required
* Provide written informed consent and agree to adhere to study restrictions and contraception requirements.

Exclusion Criteria

* Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
* Employee, or immediate family member of a study site or Sponsor employee
* Have a pregnant partner
* History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
* Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
* Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, or gastrointestinal disease, neurological or psychiatric disorder
* History of jaundice or gallstones or had a cholecystectomy
* Family history or known risk for narrow angle glaucoma
* Consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
* Any condition that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism (e.g., asthma, any chronic inflammatory condition, postural hypotension/orthostatic symptoms)
* Presence or history of clinically significant allergy
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Are taking, or have taken, any prescribed or over-the-counter drug within 14 days other than paracetamol or standard dose multivitamins. Longer restrictions apply for some medicines.
* Lactose intolerance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes