The Effect of CORT118335 on Olanzapine-Induced Weight Gain

Corcept Therapeutics

Status and phase: Completed; Phase 1

Conditions: Antipsychotic-induced Weight Gain

Treatments: Drug: Olanzapine; Drug: Placebo; Drug: CORT118335

Study type: Interventional

Funder types: Industry

Identifiers

NCT03877562

CORT118335-852

2019-000633-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

Olanzapine plus CORT118335

Experimental group

Description:

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

Treatment:

Drug: Olanzapine

Drug: CORT118335

Olanzapine plus Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Olanzapine