Poster
73
(#73) Lipid and Glycemic Profile of Olanzapine and Samidorphan: A Patient Subgroup Analysis of a 4-Year Open-Label Study
Psych Congress 2025
Abstract: INTRODUCTION: This analysis examined lipid/glycemic parameters across patient subgroups in a 4-year, open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder.
METHODS: Patients completing studies in the ENLIGHTEN clinical trial program were eligible to receive ≥2 and up to 4 years of additional treatment in a phase 3, open-label study assessing OLZ/SAM's safety, tolerability, and durability of treatment effect. Prespecified subgroup analyses were conducted by age ( 30 or ≥30 years), sex (male or female), race (Black/African American or non-Black/African American), baseline body mass index ( 25 or ≥25 kg/m2), and geographic region (US or non-US). Changes from baseline in lipid and glycemic parameters were assessed.
RESULTS: Overall, 523 patients were included; 53.7% (242/451) and 32.5% (109/335) received 2 and 4 years of treatment, respectively. At 2 years, OLZ/SAM treatment was associated with minimal mean changes from baseline in lipid parameters across subgroups, including total cholesterol (range: −10.9 to −2.1 mg/dL) and triglycerides (range: −10.2 to 2.1 mg/dL). Mean changes from baseline in glycosylated hemoglobin (HbA1c; range: 0.04% to 0.09%) and fasting glucose (range: −2.7 to 3.3 mg/dL) were small. At 4 years, mean changes from baseline remained minimal and generally similar across subgroups for total cholesterol (range: -1.3 to -15.0 mg/dL), triglycerides (range: -7.7 to 3.4 mg/dL), HbA1c (range: 0.08 to 0.13%), and fasting glucose (range: -4.3 to -1.8 mg/dL).
CONCLUSIONS: Changes in lipid/glycemic parameters following up to 4 years of OLZ/SAM treatment were minimal and generally similar across demographic/geographic subgroups.
Short Description: This analysis evaluated lipid/glycemic changes by demographic/geographic subgroups in a 4-year open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder. OLZ/SAM treatment was associated with minimal changes in cholesterol, triglycerides, glycosylated hemoglobin, and fasting glucose at 2 and 4 years that were generally consistent across subgroups. The results highlight the minimal effects of OLZ/SAM treatment for up to 4 years on lipid/glycemic parameters across diverse patient populations.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
METHODS: Patients completing studies in the ENLIGHTEN clinical trial program were eligible to receive ≥2 and up to 4 years of additional treatment in a phase 3, open-label study assessing OLZ/SAM's safety, tolerability, and durability of treatment effect. Prespecified subgroup analyses were conducted by age ( 30 or ≥30 years), sex (male or female), race (Black/African American or non-Black/African American), baseline body mass index ( 25 or ≥25 kg/m2), and geographic region (US or non-US). Changes from baseline in lipid and glycemic parameters were assessed.
RESULTS: Overall, 523 patients were included; 53.7% (242/451) and 32.5% (109/335) received 2 and 4 years of treatment, respectively. At 2 years, OLZ/SAM treatment was associated with minimal mean changes from baseline in lipid parameters across subgroups, including total cholesterol (range: −10.9 to −2.1 mg/dL) and triglycerides (range: −10.2 to 2.1 mg/dL). Mean changes from baseline in glycosylated hemoglobin (HbA1c; range: 0.04% to 0.09%) and fasting glucose (range: −2.7 to 3.3 mg/dL) were small. At 4 years, mean changes from baseline remained minimal and generally similar across subgroups for total cholesterol (range: -1.3 to -15.0 mg/dL), triglycerides (range: -7.7 to 3.4 mg/dL), HbA1c (range: 0.08 to 0.13%), and fasting glucose (range: -4.3 to -1.8 mg/dL).
CONCLUSIONS: Changes in lipid/glycemic parameters following up to 4 years of OLZ/SAM treatment were minimal and generally similar across demographic/geographic subgroups.
Short Description: This analysis evaluated lipid/glycemic changes by demographic/geographic subgroups in a 4-year open-label study of combined olanzapine/samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder. OLZ/SAM treatment was associated with minimal changes in cholesterol, triglycerides, glycosylated hemoglobin, and fasting glucose at 2 and 4 years that were generally consistent across subgroups. The results highlight the minimal effects of OLZ/SAM treatment for up to 4 years on lipid/glycemic parameters across diverse patient populations.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
