SchizophreniaPhase 3NCT06649214
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
A Phase 3 study testing Olanzapine-samidorphan； and Olanzapine in people with Schizophrenia, run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine-samidorphan； and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine-samidorphan；, Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine-samidorphan；Drug
orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks.
OlanzapineDrug
orally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine-samidorphan | Experimental | Not described Receives: Drug: Olanzapine-samidorphan； |
| Olanzapine | Active comparator | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight at Week 24.
Measured: 24 weeks
Proportion of subjects with ≥10% weight gain at Week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 654 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649214
- Sponsor's protocol ID
- QLG1130-301
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06649214
- Acronym / sponsor ID
- QLG1130-301
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 654 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine-samidorphan | Experimental | Drug: Olanzapine-samidorphan； |
| Olanzapine | Active comparator | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine-samidorphan；orally once daily, tablet, 10mg/10mg、15mg/10mg or 20mg/10mg，duration of 24 weeks. | Drug | Olanzapine-samidorphan |
| Olanzapineorally once daily, tablet, 10mg、15mg or 20mg，duration of 24 weeks. | Drug | Olanzapine |
Primary outcome
Percent change from baseline in body weight at Week 24.
Time frame: 24 weeks
Proportion of subjects with ≥10% weight gain at Week 24.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine-samidorphan； and Olanzapine in people with Schizophrenia, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Wang, PhD (+086-010-58303236, adwanggang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight at Week 24. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.