CNS Disorders  >>  Lybalvi (olanzapine/samidorphan)  >>  Phase 3
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8 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Lybalvi (olanzapine/samidorphan) / Alkermes
ENLIGHTEN-1, NCT02634346 / 2015-003373-15: A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the Study)

Completed
3
403
US, Europe, RoW
ALK3831, Olanzapine, Placebo
Alkermes, Inc.
Schizophrenia
05/17
06/17
NCT02669758 / 2015-003880-13: A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Completed
3
281
Europe, US, RoW
ALKS 3831
Alkermes, Inc.
Schizophrenia
06/18
06/18
ENLIGHTEN-2, NCT02694328: A Study of ALKS 3831 in Adults With Schizophrenia (The Study)

Checkmark Metabolic and anti-psychotic results from ENLIGHTEN-2 trial [screenshot]
Apr 2019 - Apr 2019: Metabolic and anti-psychotic results from ENLIGHTEN-2 trial [screenshot]
Checkmark From ENLIGHTEN-2 trial in comparison with olanzapine [screenshot]
Nov 2018 - Nov 2018: From ENLIGHTEN-2 trial in comparison with olanzapine [screenshot]
Completed
3
561
US
ALKS 3831, Olanzapine
Alkermes, Inc.
Schizophrenia
11/18
11/18
NCT02873208: A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Checkmark Safety and tolerability data from ENLIGHTEN-2-EXT study in schizophrenia at Psych Congress 2020
Sep 2020 - Sep 2020: Safety and tolerability data from ENLIGHTEN-2-EXT study in schizophrenia at Psych Congress 2020
Checkmark Interim results of weight, metabolic and anti-psychotic effects from ENLIGHTEN-2-EXT study [screenshot]
Apr 2019 - Apr 2019: Interim results of weight, metabolic and anti-psychotic effects from ENLIGHTEN-2-EXT study [screenshot]
Completed
3
266
US
ALKS 3831
Alkermes, Inc.
Schizophrenia
10/19
10/19
NCT03187769 / 2017-000497-11: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

Hourglass Jan 2020 - Dec 2020 : Topline data from ENLIGHTEN-EARLY trial in young adults recently diagnosed with schizophrenia, schizophreniform or bipolar I disorder
Completed
3
426
Europe, US, RoW
ALKS 3831, Olanzapine
Alkermes, Inc.
Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
12/21
01/22
NCT03201757 / 2017-000918-36: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Completed
3
524
Europe, US, RoW
ALKS 3831
Alkermes, Inc.
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
09/23
09/23
NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Recruiting
3
220
US, RoW
OLZ/SAM, ALKS 3831, LYBALVI, Olanzapine
Alkermes, Inc.
Schizophrenia, Bipolar I Disorder
09/26
09/26
NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Enrolling by invitation
3
236
US, RoW
OLZ/SAM, ALKS 3831
Alkermes, Inc.
Bipolar I Disorder, Schizophrenia
09/27
09/27

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