A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

A Randomized, Double-blind, Double-dummy, Positive Drug Parallel Controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

The goal of this [clinical trial] is to [evaluate the safety and efficacy of olanzapine-samidorphan tablets] in [adults with schizophrenia]. The main question[s] it aims to answer are:

• [question 1] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
• [question 2] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.

Inclusion Criteria:

• Subject is age 18 to 55 years, inclusive.
• Subject has a BMI of 18.0 to 30.0 kg/m2, inclusive.
• Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia.
• PANSS total score ≥ 70.

Exclusion Criteria:

• Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder, or any other psychiatric condition that could interfere with participation in the study.
• Subject poses a current suicide risk in the opinion of the investigator.
• Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder.
• Subject has a history of diabetes.
• Subject has used olanzapine, clozapine, chlorpromazine, or thioridazine at any time during the 6 months prior to screening or long-acting injectable antipsychotic medication in the last 6 months.
• Subject has taken opioid agonists within the 14 days prior to screening and/or anticipates a need to take opioid medication during the study period, or has taken opioid antagonists within 60 days prior to screening.
• Subject is taking any weight loss agents or hypoglycemic agents at screening.
• Subject has had a surgical procedure for weight loss or is planning to have liposuction during the study.
• Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy.