A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

October 17, 2024 updated by: Qilu Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

654

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Olanzapine
Drug: Olanzapine
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
Experimental: Olanzapine-samidorphan
Drug: Olanzapine-samidorphan；
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in body weight at Week 24.
Time Frame: 24 weeks
24 weeks
Proportion of subjects with ≥10% weight gain at Week 24.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLG1130-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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