A Study to Assess the Effect of Low-Dose Miricorilant on Olanzapine-Induced Weight Gain (QSC301120)
Research type
Research Study
Full title
A Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Effect of Low Dose Miricorilant on Olanzapine-Induced Weight Gain in Healthy Subjects
IRAS ID
1007798
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Research summary
The Sponsor is developing the test medicine, miricorilant, for the potential treatment of antipsychotic-induced weight gain (AIWG) and non-alcoholic steatohepatitis (NASH). AIWG is a condition in which patients taking antipsychotic medications, for the treatment of mental disorders such as schizophrenia, tend to gain weight. Antipsychotic medications also increase insulin resistance thereby increasing the risk of patients developing cardiovascular disease (diseases that affect the heart and blood vessels). NASH develops from non-alcoholic fatty liver disease, which is a range of conditions caused by a build-up of fat in the liver and is usually seen in overweight or obese people.
This one-part healthy subject proof of concept study aims to assess whether the test medicine reduces the weight gain caused by the approved medicine, olanzapine. This study will take place at one non-NHS site and will consist of a single study period involving up to 70 healthy male subjects, aged 18-55 years.
Subjects will be randomised to 1 of 2 treatment regimens in which they will be orally dosed with olanzapine (10 mg) and either miricorilant (100 mg) or placebo. All regimens will be dosed in the morning for 21 consecutive days. Subjects will be admitted to the clinical unit on the evenings of Days -1, 7, 14 and 21, and dosed in the clinical unit on Days 1 to 4, Day 8 and Day 15. Subjects will be discharged from the clinical unit following dosing on Days 4, 8 and 15 and will proceed with home dosing on Days 5 to 7, Days 9 to 14, and Days 16 to 21. Subjects will be discharged for the last time on Day 22 and will return 12 to 16 days post-final test medicine dose for a follow-up visit.
Subject’s blood will be taken during the study for analysis of the test medicine. Subject’s blood and urine will also be collected for safety testing. Subjects are expected to be involved in this study for approximately 9 weeks from screening to the follow-up visit.
REC name
HSC REC A
REC reference
23/NI/0058
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion