Effect of CORT118335 on Olanzapine-Induced Weight Gain (QSC202012)
Research type
Research Study
Full title
A Two-Part Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
IRAS ID
260048
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2019-000633-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
The Sponsor is developing the test medicine, CORT118335, for the potential treatment of antipsychotic-induced weight gain.
Antipsychotic-induced weight gain (AIWG) is the condition in which patients taking antipsychotic medications (e.g. olanzapine) have a tendency to gain weight. In addition to weight gain, antipsychotic medications increase insulin resistance and cholesterol and triglycerides (types of fat) in the blood, thereby increasing the patient's cardiovascular risk.
The study will try to identify volunteers' average change in absolute body weight from baseline following 14 days of co-administration of the test medicine and olanzapine, an antipsychotic known to cause weight gain.
The study is a single-centre, double-blind, randomised, placebo-controlled assessment of the effect of CORT118335 on weight gain induced by multiple doses of olanzapine in healthy male subjects. The study will enroll up to 64 healthy male volunteers to receive multiple doses of 600 mg (2 x 300 mg or 6 x 100 mg) CORT118335 tablet or matching placebo (dummy medicine). Volunteers will be randomised in a 1:1 ratio to receive the test medicine or matching placebo, co-administered with 10 mg olanzapine, for 14 consecutive days. Volunteers will remain in the clinical unit for 24 hours after the last dose (Day 15).
A follow-up visit will take place approximately 14 days after the last dose to ensure the ongoing well-being of the volunteers.
REC name
HSC REC A
REC reference
19/NI/0036
Date of REC Opinion
4 Mar 2019
REC opinion
Favourable Opinion