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The Effect of CORT118335 on Olanzapine-Induced Weight Gain

NCT03877562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-04-28

No results posted yet for this study

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

Interventions

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-13
Completion
2020-03-25

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877562 on ClinicalTrials.gov