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

NCT ID NCT05303064

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

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.

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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

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WITHDRAWN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WITHDRAWN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WITHDRAWN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WITHDRAWN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WITHDRAWN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WITHDRAWN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

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