A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Olanzapine-samidorphan；

Drug: Olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06649214

QLG1130-301

Details and patient eligibility

About

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.

Enrollment

654 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.