Richardson

Researchers are evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia who have had inadequate responses, side effects, or issues with their current antipsychotic medications, or who have completed prior LB-102 studies. This Phase 3, open-label, multicenter trial focuses on patients aged 18 to 65 years with stable disease and aims to provide extended monitoring of this treatment. Participants will receive LB-102 with flexible dosing ranging from 50 mg to 100 mg. This single-group study involves administering the drug openly over 52 weeks to assess how well patients tolerate it and to monitor safety during this period. Throughout the study, participants will undergo evaluations including monitoring adverse events and treatment-emergent events. Effectiveness will be assessed using the Positive and Negative Syndrome Scale PANSS. The study lasts up to 52 weeks, during which safety and tolerability are carefully observed and recorded.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

Researchers are evaluating the efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are studying the investigational drug LTX-001 to determine its safety and tolerability in adults diagnosed with schizophrenia who are experiencing a recent worsening of symptoms, known as an acute exacerbation. This early-phase trial also examines how the drug behaves in the body over time, how it affects schizophrenia symptoms, and changes in certain blood markers after taking LTX-001. Participants will be randomly assigned to receive different doses of LTX-001 or a placebo to compare effects. Eligible participants will stay overnight in a research unit for about five weeks, or up to 49 nights if they require up to 14 days to stop current antipsychotic medications before starting the study drug. They will take LTX-001 or placebo orally once or twice daily depending on the assigned dose. During the trial, participants will visit the study site three times for assessments including medical history review, physical and neurological exams, heart monitoring, blood and urine tests, psychiatric evaluations, and eye exams. Throughout the study and until Day 42, researchers will monitor participants for safety by tracking adverse events, lab tests, vital signs, heart activity, neurological exams, and suicidality risk. They will also assess drug levels in the body on specific days. After the treatment period, participants return for a follow-up visit one week later. Assessments include symptom scales, cognitive tests, and detailed psychiatric and physical evaluations to understand the drugs effects and safety profile.

Researchers are evaluating the safety and side effects of the drug PF-08046054SGN-PDL1V alone and in combination with pembrolizumab in participants with advanced solid tumors. These tumors are either metastatic, meaning they have spread through the body, or unresectable, meaning they cannot be removed by surgery. The study is a Phase 1 trial designed to find the best dose and assess safety and potential treatment effects in these cancers. The study has five parts Parts A and B focus on determining the appropriate dose of PF-08046054SGN-PDL1V. Part C uses the dose found to further evaluate safety and potential effectiveness of the drug alone. Parts D and E study the combination of PF-08046054SGN-PDL1V with pembrolizumab, given intravenously, to assess safety and possible benefits. Pembrolizumab is administered at 200 mg every three weeks. Participants will undergo assessments for side effects, laboratory abnormalities, and dose-limiting toxicities over about one month initially, with follow-up for up to three years to monitor longer-term outcomes like tumor response and survival. Safety monitoring includes tracking adverse events and immune responses to the drug. The study involves regular evaluations to measure tumor changes using standard criteria and to understand how the drugs behave in the body over time.

Researchers are evaluating the safety, tolerability, and feasibility of aticaprant as an additional treatment for adults with schizophrenia. This phase 1b study aims to see how well participants with schizophrenia can enroll and complete the study assessments while comparing aticaprant to a placebo. The study focuses on participants who are clinically stable and already receiving outpatient treatment for schizophrenia. Participants are randomly assigned to receive either aticaprant or a placebo during the double-blind treatment phase. The study involves monitoring participants over several weeks, with safety and tolerability assessments including adverse events, vital signs, ECGs, laboratory tests, body weight and BMI changes, suicidality assessments, and extrapyramidal symptom evaluations. The study is designed to last up to 126 days for most outcomes, with some measurements taken up to 84 days. Throughout the study, participants will undergo various assessments to evaluate safety and tolerability, including the Columbia Suicide Severity Rating Scale and the Modified Simpson-Angus Scale for extrapyramidal symptoms. Blood samples will confirm medication adherence, and the study will track completion rates of assessments and overall study participation. This detailed monitoring helps researchers understand how participants tolerate aticaprant as an add-on therapy in schizophrenia treatment.

This research aims to evaluate the safety and effectiveness of Icalcaprant in adults diagnosed with bipolar I or II disorder, specifically focusing on depressive episodes. Bipolar disorder is a chronic mood condition affecting a significant portion of the adult and pediatric populations in the United States. The study targets approximately 195 adult participants across about 35 sites in the U.S., aiming to understand how Icalcaprant impacts disease activity and adverse events. Participants are randomly assigned to one of three groups two groups receive different doses of oral Icalcaprant once daily for 6 weeks, and one group receives a matching placebo daily for the same period. After the treatment phase, all participants enter a 4-week safety follow-up period. The study uses a parallel design with quadruple masking to compare the effects of the investigational drug versus placebo. During the study, participants will attend regular visits at hospitals or clinics where they undergo medical assessments, blood tests, and complete questionnaires to monitor side effects and treatment effects. Researchers will measure changes from baseline to week 6 in depression severity using the Montgomery-sberg Depression Rating Scale and the Clinician Global Impression of Severity for bipolar disorder. Safety will be monitored up to approximately 10 weeks, ensuring participant well-being throughout the trial.

Schizophrenia is a serious psychiatric illness marked by significant disturbances in thinking, language, perception, and self-awareness. Researchers are evaluating the safety, effects on disease activity, and how the investigational drug emraclidine is processed in the body in adults with schizophrenia. This is a Phase 2 study designed to explore these aspects with careful monitoring. Participants are divided into two parts. In Part A, participants receive different increasing doses of oral emraclidine or placebo for 14 to 21 days. In Part B, participants receive oral emraclidine or placebo for up to 42 days. Following treatment, all participants enter a 30-day safety follow-up to monitor any lasting effects. During the study, participants will attend regular clinic visits for medical exams, blood tests, and questionnaires to check for side effects and disease changes. Researchers will measure adverse events, drug levels in the blood, and changes in schizophrenia symptoms using specific scales. The total participation time may be up to about 74 days including treatment and follow-up.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.