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The Effect of CORT118335 on Olanzapine-Induced Weight Gain

Primary Purpose

Antipsychotic-induced Weight Gain

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Olanzapine

CORT118335

Placebo

About this trial

This is an interventional prevention trial for Antipsychotic-induced Weight Gain

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts 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.

Sites / Locations

Quotient Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Olanzapine plus CORT118335

Olanzapine plus Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Change from Baseline in Body Weight

Secondary Outcome Measures

Percentage of Participants with One or More Adverse Events

Percentage of Participants with One or More Serious Adverse Events

Percentage of Participants Discontinued from the Study due to an Adverse Event

Mean Change from Baseline in Glucose

Mean Change from Baseline in Insulin

Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Mean Change from Baseline in Triglycerides

Mean Change from Baseline in Waist-to-Hip Ratio

Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)

Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)

Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)

Full Information

NCT ID

NCT03877562

First Posted

March 14, 2019

Last Updated

April 24, 2020

Sponsor

Corcept Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03877562

Brief Title

The Effect of CORT118335 on Olanzapine-Induced Weight Gain

Official Title

A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

March 13, 2020 (Actual)

Study Completion Date

March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antipsychotic-induced Weight Gain

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine plus CORT118335

Arm Type

Experimental

Arm Description

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

Arm Title

Olanzapine plus Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

Olanzapine 10 mg oral tablet

Intervention Type

Drug

Intervention Name(s)

CORT118335

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change from Baseline in Body Weight

Time Frame

Pre-dose on Day 1 (Baseline) and Day 15

Secondary Outcome Measure Information:

Title

Percentage of Participants with One or More Adverse Events

Time Frame

Up to Day 28

Title

Percentage of Participants with One or More Serious Adverse Events

Time Frame

Up to Day 28

Title

Percentage of Participants Discontinued from the Study due to an Adverse Event

Time Frame

Up to Day 28

Title

Mean Change from Baseline in Glucose

Time Frame

Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28

Title

Mean Change from Baseline in Insulin

Time Frame

Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28

Title

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

Title

Mean Change from Baseline in Triglycerides

Time Frame

Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28

Title

Mean Change from Baseline in Waist-to-Hip Ratio

Time Frame

Pre-dose on Day 1 (Baseline), Days 8, 15, and 28

Title

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

Title

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharan Sidhu, MBChB, BAO, MRCS, MFPM

Organizational Affiliation

Quotient Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quotient Sciences

City

Ruddington

State/Province

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of CORT118335 on Olanzapine-Induced Weight Gain

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