A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
Phase 3
Not yet recruiting
- Conditions
- Schizophrenia
- Interventions
- Drug: Olanzapine-samidorphan；
- Registration Number
- NCT06649214
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 654
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine-samidorphan Olanzapine-samidorphan； - Olanzapine Olanzapine -
- Primary Outcome Measures
Name Time Method Proportion of subjects with ≥10% weight gain at Week 24. 24 weeks Percent change from baseline in body weight at Week 24. 24 weeks
- Secondary Outcome Measures
Name Time Method