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Completed

NCT Number: NCT03877562

The Effect of CORT118335 on Olanzapine-Induced Weight Gain

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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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olanzapine

Drug

Olanzapine 10 mg oral tablet

CORT118335

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Mean Change from Baseline in Body Weight

    Time frame: Pre-dose on Day 1 (Baseline) and Day 15

Secondary outcomes

  1. Percentage of Participants with One or More Adverse Events

    Time frame: Up to Day 28

  2. Percentage of Participants with One or More Serious Adverse Events

    Time frame: Up to Day 28

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

    Time frame: Up to Day 28

  4. Mean Change from Baseline in Glucose

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

  5. Mean Change from Baseline in Insulin

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

  6. 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

  7. Mean Change from Baseline in Triglycerides

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

  8. Mean Change from Baseline in Waist-to-Hip Ratio

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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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