A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

NCT06649214 | Not Yet Recruiting Phase 3

• 1 other identifier: QLG1130-301
• Study Type: interventional
• Target: 654
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Percent change from baseline in body weight at Week 24.

  24 weeks

• Proportion of subjects with ≥10% weight gain at Week 24.

  24 weeks

Study Arms (2)

Olanzapine-samidorphan

EXPERIMENTAL

Drug: Olanzapine-samidorphan；

Olanzapine

ACTIVE COMPARATOR

Drug: Olanzapine

Interventions

Olanzapine-samidorphan； DRUG

orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.

Olanzapine-samidorphan

Olanzapine DRUG

orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.

Olanzapine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Gang Wang, PhD

CONTACT

+086-010-58303236; adwanggang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10