~70 spots leftby Sep 2026

OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder

Recruiting at 62 trial locations
GC
KA
CV
JK
MH
AH
BL
SY
TK
LP
Overseen ByLori Penatzer
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alkermes, Inc.
Must be taking: Antipsychotics
Must not be taking: Opioids, Opioid antagonists
Disqualifiers: Major depressive episode, Seizure disorder, Diabetes, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it seems you can continue if you are currently treated with olanzapine. If you are on another antipsychotic, you may need to switch if it hasn't been effective.

What data supports the effectiveness of the drug OLZ/SAM for treating schizophrenia or bipolar disorder?

Research shows that OLZ/SAM combines the effectiveness of olanzapine, a strong antipsychotic, with samidorphan to reduce weight gain, a common side effect of olanzapine, making it a promising option for treating schizophrenia and bipolar I disorder.12345

Is OLZ/SAM safe for humans?

OLZ/SAM, a combination of olanzapine and samidorphan, has been studied for its safety in humans, particularly for schizophrenia and bipolar I disorder. Research shows it aims to reduce weight gain associated with olanzapine while maintaining its effectiveness, and long-term studies have assessed its safety and tolerability over a year.12345

What makes the drug OLZ/SAM unique for treating schizophrenia or bipolar disorder?

OLZ/SAM is unique because it combines olanzapine, a powerful antipsychotic, with samidorphan, which helps reduce the weight gain often caused by olanzapine, making it a more tolerable option for long-term use.12345

Research Team

DM

David McDonnell, MD

Principal Investigator

Alkermes, Inc.

Eligibility Criteria

This trial is for young people aged 10-17 with bipolar I disorder or schizophrenia. They must be diagnosed by DSM-5 criteria, have family support, and can't be a danger to themselves or others. Participants should either be on olanzapine already or not responding well to other antipsychotics.

Inclusion Criteria

I am a teenager diagnosed with schizophrenia or bipolar I disorder.
I can receive treatment without staying in the hospital.
Subject has reliable family/legal guardian support available for outpatient management
See 2 more

Exclusion Criteria

Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline C-SSRS
Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening
I have received a long-acting injectable antipsychotic within the last 3 injection cycles.
See 9 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OLZ/SAM or olanzapine to evaluate weight gain as assessed by change in BMI Z-score

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Olanzapine (Atypical Antipsychotic)
  • OLZ/SAM (Atypical Antipsychotic)
Trial OverviewThe study compares the effect of OLZ/SAM versus olanzapine alone on BMI Z-score in youth with schizophrenia or bipolar I disorder. It aims to see if OLZ/SAM leads to less weight gain than olanzapine, which is known for causing weight increase.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 OLZ/SAMExperimental Treatment1 Intervention
Fixed dose combination of olanzapine and samidorphan
Group II: Group 2 OlanzapineActive Control1 Intervention
Fixed dose of olanzapine

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials
118
Recruited
27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Findings from Research

In a 52-week study involving 281 patients with schizophrenia, the combination of olanzapine and samidorphan (OLZ/SAM) was generally well tolerated, with most patients completing the treatment and showing sustained improvement in schizophrenia symptoms as measured by PANSS and CGI-S scores.
While there was a mean weight increase of 1.86 kg over the year, this change stabilized early in the treatment, suggesting that OLZ/SAM may effectively mitigate the weight gain typically associated with olanzapine.
Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study.Yagoda, S., Graham, C., Simmons, A., et al.[2022]
Olanzapine-samidorphan (OLZ/SAM) is a newly FDA-approved medication that effectively combines the antipsychotic properties of olanzapine with samidorphan to help reduce weight gain associated with olanzapine treatment.
While OLZ/SAM is effective in mitigating weight gain, it does not promote weight loss and has limited effects on metabolic laboratory variables, indicating a need for further research to compare its effectiveness with other weight management strategies in antipsychotic treatment.
Olanzapine-samidorphan combination tablets for the treatment of schizophrenia and bipolar I disorder - what is it, and will it be used?Faden, J., Serdenes, R., Citrome, L.[2022]
The olanzapine/samidorphan (OLZ/SAM) combination treatment significantly reduces the risk of clinically significant weight gain (>10%) compared to olanzapine (OLZ) monotherapy in adults with schizophrenia, with an odds ratio of 0.50.
OLZ/SAM maintains similar clinical efficacy to OLZ while improving tolerability, indicating it may be a preferable option for managing schizophrenia without the added risk of significant weight gain.
Olanzapine and samidorphan combination treatment: A systematic review.Jawad, MY., Alnefeesi, Y., Lui, LMW., et al.[2022]

References

Long-term safety and durability of effect with a combination of olanzapine and samidorphan in patients with schizophrenia: results from a 1-year open-label extension study. [2022]
Olanzapine-samidorphan combination tablets for the treatment of schizophrenia and bipolar I disorder - what is it, and will it be used? [2022]
Olanzapine and samidorphan combination treatment: A systematic review. [2022]
A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: Results from the ENLIGHTEN-2 long-term extension. [2022]
Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder. [2023]