Lybalvi is a prescription medication approved for the treatment of adults with schizophrenia and bipolar I disorder. It is an oral, once-daily atypical antipsychotic. It combines two active compounds: olanzapine, an established antipsychotic, and samidorphan, a new chemical entity. Lybalvi is available in various fixed dosage strengths, combining 10 mg of samidorphan with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
Lybalvi and Weight Changes
Lybalvi is not considered “weight-neutral,” but it aims to mitigate weight gain compared to olanzapine alone. While olanzapine is known for its association with weight gain, samidorphan’s inclusion is intended to counteract this effect. Clinical trials have investigated Lybalvi’s impact on body weight.
In a 24-week study (ENLIGHTEN-2), patients taking Lybalvi experienced a significantly lower mean percentage weight gain compared to those taking olanzapine alone. At the end of 24 weeks, the olanzapine-subtracted difference in percentage change from baseline in body weight with Lybalvi was -2.4%.
Fewer patients taking Lybalvi experienced a weight gain of 10% or more from baseline at Week 24, with the risk reduced by 50% compared to olanzapine. While Lybalvi generally leads to less weight gain than olanzapine alone, some individuals may still experience weight changes. Weight gain is a possible side effect, reported by up to 25% of users in clinical trials.
Factors Contributing to Weight Impact
The weight profile of Lybalvi stems from the combined actions of its two components. Olanzapine, a known atypical antipsychotic, has an association with metabolic side effects, including weight gain. This weight gain can be attributed to its interaction with various receptors in the brain.
Olanzapine’s antagonism of certain receptors, particularly serotonin 2C (5-HT2C) and histamine H1 receptors, is implicated in its weight-increasing effects. Antagonism of the 5-HT2C receptor can lead to increased food intake, or hyperphagia, a driver of weight gain. Additionally, olanzapine’s sedative effects, potentially related to histamine H1 receptor antagonism, may contribute to reduced physical activity, influencing weight.
Samidorphan, the second component of Lybalvi, acts as an opioid antagonist. It is thought to mitigate olanzapine’s metabolic effects, including weight gain, without compromising antipsychotic efficacy. Samidorphan is hypothesized to achieve this by affecting sugar uptake and preventing insulin resistance, particularly through its action on the mu-opioid receptor. Data suggest that targeting the endogenous opioid system can help address antipsychotic-associated weight gain and metabolic dysregulation.
Weight Management Strategies
Managing weight changes while taking Lybalvi involves an approach integrating lifestyle adjustments and professional guidance. Regular monitoring of body weight is a step, and open communication with healthcare providers about any concerns is recommended. This allows for timely adjustments and personalized advice.
Dietary considerations play a role in weight management. Emphasizing balanced nutrition, practicing portion control, and limiting processed foods can support a healthier weight. Choosing nutrient-dense foods and avoiding excessive high-fat, sugary, or greasy items is beneficial.
Incorporating regular physical activity into one’s routine is a helpful strategy. Engaging in exercise suitable for the individual can contribute to calorie expenditure and metabolic health. Even moderate activity can make a difference in managing weight.
For personalized advice and management plans, consulting a doctor, dietitian, or other healthcare professional is recommended. These professionals can offer tailored dietary guidance, exercise recommendations, and help address any weight changes or metabolic concerns that may arise during treatment. Working closely with the healthcare team ensures an effective approach to maintaining well-being.