The Effect of CORT118335 on Olanzapine-Induced Weight Gain

NCT03877562 | Completed Phase 1

• 2 other identifiers: CORT118335-8522019-000633-39
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Antipsychotic-induced Weight Gain

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in Body Weight

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

Secondary Outcomes (11)

• Percentage of Participants with One or More Adverse Events

  Up to Day 28

• Percentage of Participants with One or More Serious Adverse Events

  Up to Day 28

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

  Up to Day 28

• Mean Change from Baseline in Glucose

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

• Mean Change from Baseline in Insulin

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

Study Arms (2)

Olanzapine plus CORT118335

EXPERIMENTAL

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

Drug: Olanzapine; Drug: CORT118335

Olanzapine plus Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Olanzapine DRUG

Olanzapine 10 mg oral tablet

Olanzapine plus CORT118335; Olanzapine plus Placebo

CORT118335 DRUG

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

Olanzapine plus CORT118335

Placebo DRUG

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

Olanzapine plus Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Olanzapine; CORT118335

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: April 1, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 25, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)