Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo pill aims to curb weight gain in teens on antipsychotics

NCT ID NCT05303064

Disease control Sponsor: Alkermes, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study tests whether a combination drug called OLZ/SAM (olanzapine plus samidorphan) causes less weight gain than olanzapine alone in teenagers with schizophrenia or bipolar I disorder. About 220 teens aged 10-17 will take either the combo or olanzapine for 52 weeks. The main goal is to see if the combo leads to a smaller increase in body mass index (BMI).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OLZ/SAM (olanzapine and samidorphan combination)
What this could lead to
If successful, this could offer a way to control psychiatric symptoms with less weight gain, improving long-term health for teens.
What could go wrong
This is an early Phase 3 trial with only 220 participants, so results may not apply to everyone. Weight gain may still occur, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria * Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2 * Subject has reliable family/legal guardian support available for outpatient management * Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment * Subject must not be a danger to self or others (per Investigator judgement) Exclusion Criteria: * Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study * Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening * Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS) * Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine * Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists) * Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery) * Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening * Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening * Subject has a BMI percentile \>98th or \<5th * Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%) * Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening * Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bipolar I disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bipolar I disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar I disorder Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alkermes Investigational Site

    WITHDRAWN

    Kinston, North Carolina, 28504, United States

  • Alkermes Investigational Site

    RECRUITING

    Richmond, Virginia, 23220, United States

  • Alkermes Investigator Site

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Alkermes Investigator Site

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Encino, California, 91316, United States

  • Alkermes Investigator Site

    RECRUITING

    Stanford, California, 94305, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Upland, California, 91786, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Colorado Springs, Colorado, 80910, United States

  • Alkermes Investigator Site

    ACTIVE_NOT_RECRUITING

    Denver, Colorado, 80202, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Hartford, Connecticut, 06106, United States

  • Alkermes Investigator Site

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Miami, Florida, 33155, United States

  • Alkermes Investigator Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Alkermes Investigator Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Alkermes Investigator Site

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Alkermes Investigator Site

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Alkermes Investigator Site

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Alkermes Investigator Site

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Omaha, Nebraska, 68198, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Paramus, New Jersey, 07652, United States

  • Alkermes Investigator Site

    RECRUITING

    New York, New York, 10016, United States

  • Alkermes Investigator Site

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Alkermes Investigator Site

    RECRUITING

    West Chester, Ohio, 45069, United States

  • Alkermes Investigator Site

    TERMINATED

    DeSoto, Texas, 75115, United States

  • Alkermes Investigator Site

    WITHDRAWN

    Fort Worth, Texas, 76104, United States

  • Alkermes Investigator Site

    RECRUITING

    Everett, Washington, 98201, United States

  • Alkermes Investigator Site

    RECRUITING

    La Plata, Buenos Aires, 1900, Argentina

  • Alkermes Investigator Site

    RECRUITING

    La Plata, Buenos Aires, C1199ABB, Argentina

  • Alkermes Investigator Site

    RECRUITING

    Buenos Aires, C1133AAH, Argentina

  • Alkermes Investigator Site

    RECRUITING

    Córdoba, X5003DCE, Argentina

  • Alkermes Investigator Site

    RECRUITING

    Mendoza, 5500, Argentina

  • Alkermes Investigator Site

    RECRUITING

    Fortaleza, Ceará, 60430-140, Brazil

  • Alkermes Investigator Site

    RECRUITING

    Curitiba, Paraná, 80240-280, Brazil

  • Alkermes Investigator Site

    RECRUITING

    Goiânia, 74093-040, Brazil

  • Alkermes Investigator Site

    RECRUITING

    Rio de Janeiro, 22270-060, Brazil

  • Alkermes Investigator Site

    RECRUITING

    São Paulo, 01228-000, Brazil

  • Alkermes Investigator Site

    RECRUITING

    São Paulo, 05403-010, Brazil

  • Alkermes Investigator Site

    RECRUITING

    Barranquilla, 110121, Colombia

  • Alkermes Investigator Site

    RECRUITING

    Bello, 51053, Colombia

  • Alkermes Investigator Site

    ACTIVE_NOT_RECRUITING

    Bogotá, 111166, Colombia

  • Alkermes Investigator Site

    RECRUITING

    Bogotá, 80020, Colombia

  • Alkermes Investigator Site

    RECRUITING

    Pereira, 660003, Colombia

  • Alkermes Investigator Site

    RECRUITING

    Culiacán, 80230, Mexico

  • Alkermes Investigator Site

    RECRUITING

    Estado de México, C.P. 07000, Mexico

  • Alkermes Investigator Site

    RECRUITING

    León, 37000, Mexico

  • Alkermes Investigator Site

    RECRUITING

    Monterrey, 64620, Mexico

  • Alkermes Investigator Site

    RECRUITING

    Monterrey, 64710, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.