The Effect of CORT118335 on Olanzapine-Induced Weight Gain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03877562 |
Recruitment Status :
Completed
First Posted : March 15, 2019
Last Update Posted : April 28, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Antipsychotic-induced Weight Gain | Drug: Olanzapine Drug: CORT118335 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects |
Actual Study Start Date : | April 1, 2019 |
Actual Primary Completion Date : | March 13, 2020 |
Actual Study Completion Date : | March 25, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Olanzapine plus CORT118335
Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.
|
Drug: Olanzapine
Olanzapine 10 mg oral tablet Drug: CORT118335 CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets |
Placebo Comparator: 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.
|
Drug: Olanzapine
Olanzapine 10 mg oral tablet Drug: Placebo Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877562
United Kingdom | |
Quotient Sciences | |
Ruddington, Nottingham, United Kingdom, NG11 6JS |
Principal Investigator: | Sharan Sidhu, MBChB, BAO, MRCS, MFPM | Quotient Sciences |
Responsible Party: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT03877562 |
Other Study ID Numbers: |
CORT118335-852 2019-000633-39 ( EudraCT Number ) |
First Posted: | March 15, 2019 Key Record Dates |
Last Update Posted: | April 28, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Body Weight Weight Gain Body Weight Changes Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |