Sigulda

Researchers are conducting a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate the effectiveness, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. The study focuses on participants aged 18 to 75 years who have this diagnosis and are still experiencing hyperthyroidism. Participants will receive either IMVT-1402 or a placebo for 26 weeks. The study includes two dosing regimens of IMVT-1402: Dose 1 administered for 26 weeks and Dose 2 also administered for 26 weeks. The placebo group will receive treatment for the same duration. The treatments are given as drugs, and the study is designed to keep both participants and researchers unaware of which treatment is assigned. During the study, researchers will monitor participants to see how many achieve normal thyroid function (euthyroid) and remain off antithyroid drugs by Week 26. Participants will be assessed regularly to evaluate safety, tolerability, and treatment effects. The involvement includes following the assigned treatment and attending scheduled visits for evaluations. The total participation time corresponds with the 26-week treatment period.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on participants who have moderate to severe depressive symptoms and have not responded adequately to oral antidepressant treatments during their current episode. This is a Phase 3 trial aiming to improve symptoms of depression by adding NBI-1065845 to existing antidepressant therapy. Participants will receive either NBI-1065845 tablets or matching placebo tablets alongside their current oral antidepressant medication, which they must continue at the same dose and frequency. The study compares these two groups to assess the added benefit of NBI-1065845 as an adjunctive therapy. During the study, participants will be assessed for changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and on Day 56. Researchers will monitor safety and efficacy throughout the study period. Participants must comply with all study procedures and restrictions, with the total participation duration covering at least 56 days to evaluate treatment effects.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.