Poster
95
(#95) Evaluating Long-Term Weight Gain and Other Metabolic Changes With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Results From the Phase 3 SOLARIS Trial
Psych Congress 2025
Abstract: TV-44749 is an innovative, subcutaneous, long-acting injectable olanzapine for treatment of schizophrenia, designed to provide sustained efficacy and eliminate the risk of post-injection delirium/sedation syndrome.
SOLARIS (NCT05693935) evaluated the efficacy and safety of TV-44749 in adults with acute exacerbation of schizophrenia in an 8-week, randomized, double-blind, placebo-controlled period (Period [P] 1) with an open-label, long-term safety period of ≤48 weeks (P2). In P1, participants were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, 531mg) or placebo. In P2, P1 TV-44749 participants retained treatment; P1 placebo participants were rerandomized 1:1:1 to TV-44749 dosages. Weight gain and metabolic changes (adverse events [AEs], and laboratory parameter shifts) were evaluated.
During the trial, 253/604 participants (42%) receiving TV-44749 reported ≥1 metabolic AE; 'weight increased' was reported in 36% of participants. In P1, participants who received TV-44749 (n=358) experienced an increase in mean weight from baseline to week 8 versus placebo (n=119): 6.87kg versus 2.31kg. In P2, ex-placebo participants had a steeper mean weight increase versus those who remained on TV-44749. By week 32, all groups reached a similar mean weight increase versus baseline, which thereafter remained stable. Mean weight increases from baseline for participants with any TV-44749 exposure duration (n=311) and with ≥48 weeks' exposure duration (n=137) were 6.61kg and 5.61kg, respectively. Other metabolic AE rates and shifts in metabolic laboratory parameters were comparable with the established olanzapine safety profile. Treatment and/or trial discontinuation due to metabolic AEs was low.
In conclusion, long-term metabolic safety data for TV-44749 were consistent with currently available olanzapine formulations.
Short Description: Weight gain and metabolic changes with TV-44749 in the SOLARIS trial were investigated. Overall, the long-term safety profile of TV-44749 for changes in body weight and other metabolic parameters was comparable with the established safety profile for olanzapine. Specifically, the overall mean weight change from baseline in participants who received TV-44749 for ≥48 weeks (5.61kg) and the extent of metabolic changes were comparable to those reported for oral and intramuscular olanzapine formulations.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
SOLARIS (NCT05693935) evaluated the efficacy and safety of TV-44749 in adults with acute exacerbation of schizophrenia in an 8-week, randomized, double-blind, placebo-controlled period (Period [P] 1) with an open-label, long-term safety period of ≤48 weeks (P2). In P1, participants were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, 531mg) or placebo. In P2, P1 TV-44749 participants retained treatment; P1 placebo participants were rerandomized 1:1:1 to TV-44749 dosages. Weight gain and metabolic changes (adverse events [AEs], and laboratory parameter shifts) were evaluated.
During the trial, 253/604 participants (42%) receiving TV-44749 reported ≥1 metabolic AE; 'weight increased' was reported in 36% of participants. In P1, participants who received TV-44749 (n=358) experienced an increase in mean weight from baseline to week 8 versus placebo (n=119): 6.87kg versus 2.31kg. In P2, ex-placebo participants had a steeper mean weight increase versus those who remained on TV-44749. By week 32, all groups reached a similar mean weight increase versus baseline, which thereafter remained stable. Mean weight increases from baseline for participants with any TV-44749 exposure duration (n=311) and with ≥48 weeks' exposure duration (n=137) were 6.61kg and 5.61kg, respectively. Other metabolic AE rates and shifts in metabolic laboratory parameters were comparable with the established olanzapine safety profile. Treatment and/or trial discontinuation due to metabolic AEs was low.
In conclusion, long-term metabolic safety data for TV-44749 were consistent with currently available olanzapine formulations.
Short Description: Weight gain and metabolic changes with TV-44749 in the SOLARIS trial were investigated. Overall, the long-term safety profile of TV-44749 for changes in body weight and other metabolic parameters was comparable with the established safety profile for olanzapine. Specifically, the overall mean weight change from baseline in participants who received TV-44749 for ≥48 weeks (5.61kg) and the extent of metabolic changes were comparable to those reported for oral and intramuscular olanzapine formulations.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
