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Trial + Data / Events	Status	Ph	N	Region	Interventions	Sponsor	Conditions	Primary compl	Study compl
Lybalvi (olanzapine/samidorphan) / Alkermes
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
NCT05547100: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan	Completed	1	12	US	LYBALVI, Olanzapine/samidorphan (OLZ/SAM), ALKS 3831	Alkermes, Inc.	Focus of Study is on Healthy Lactating Women	11/22	11/22
NCT04987658: Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder	Completed	1	7	US	OLZ/SAM, ALKS 3831	Alkermes, Inc.	Bipolar I Disorder	08/23	08/23