A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
NCT ID: NCT06649214
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
654 participants
INTERVENTIONAL
2024-11-30
2026-05-31
Brief Summary
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* \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine.
* \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olanzapine-samidorphan
Olanzapine-samidorphan；
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.
Olanzapine
Olanzapine
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
Interventions
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Olanzapine-samidorphan；
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.
Olanzapine
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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QLG1130-301
Identifier Type: -
Identifier Source: org_study_id
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