Varazdin

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are studying participants with Relapsing Multiple Sclerosis (RMS) to compare how the body processes ublituximab when given as a subcutaneous (under the skin) injection versus an intravenous (IV) infusion. This Phase 3, open-label, parallel-group, multicenter study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological, and clinical effects of these two methods of administering ublituximab. The purpose is to understand if the subcutaneous form is not inferior to the intravenous form. Participants will receive ublituximab either by IV infusion or subcutaneous injection. The study includes ongoing treatment and monitoring to assess how the drug behaves in the body and its effects. The comparison focuses on the area under the curve (AUC) of ublituximab concentration from the start of treatment through 24 weeks. During the study, participants will undergo assessments including clinical evaluations and radiological tests to monitor disease status and treatment effects. Safety and pharmacodynamic measures will be recorded throughout the study. The total treatment and observation period includes at least 24 weeks of follow-up to evaluate the drug's profile and impact on participants with RMS.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults who have excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well it helps participants lose weight. The study focuses on adults diagnosed with type 2 diabetes at least 180 days before screening, who have a specific range of blood sugar levels (HbA1c between 7-10%). Participants receive treatments as weekly injections under the skin using a pre-filled pen injector (PDS290) applied to the thigh, abdomen, or upper arm. They are randomly assigned to receive either NNC0487-0111 or a placebo that looks like the active treatment but contains no medicine. The study treatments are given once a week throughout the trial. During the study, participants are monitored for changes in their body weight from the start of the trial up to week 84. Researchers also assess safety and other health measures. Participants continue their usual treatment with lifestyle changes or certain oral diabetes medications that have been stable before joining. The trial follows them closely to evaluate how the treatment affects their weight and diabetes control over time.

This research aims to evaluate whether the drug CYB704, a proposed biosimilar to Ocrevus, works similarly to the original Ocrevus treatment in adults with relapsing multiple sclerosis (RMS). The study focuses on comparing how CYB704 is distributed in the body, its treatment effects, and side effects to those of Ocrevus. It is a Phase 3 clinical trial that seeks to demonstrate pharmacokinetic similarity and assess efficacy, safety, pharmacodynamics, and immunogenicity. Participants will receive either CYB704 or Ocrevus (from the US or EU) through intravenous infusions. The study is randomized, double-blind, and parallel-group in design. Participants will undergo at least 15 treatment visits involving drug administration and clinical checkups. Regular magnetic resonance imaging (MRI) scans will be performed to monitor disease activity and treatment effects. Throughout the study, participants will have various assessments including neurological evaluations and safety monitoring. The primary outcome measure focuses on the area under the concentration-time curve during weeks 1 to 3 and weeks 3 to 25 to assess drug pharmacokinetics. The total involvement includes treatment visits, MRI scans, and clinical tests to provide comprehensive data on the effects and safety of the treatments over time.

Researchers are evaluating the diagnostic and prognostic value of two novel blood-based inflammation markers, the systemic immune-inflammatory index (SII) and the systemic inflammation response index (SIRI), in adults with overweight or obesity. This study aims to understand how these markers relate to obesity severity, metabolic complications, lifestyle habits, dietary patterns, and other established inflammatory biomarkers. The goal is to see if SII and SIRI can help predict metabolic risks and treatment responses in obesity. Participants will undergo a series of assessments including body measurements, blood tests, dietary evaluations, and lifestyle questionnaires at the start, 12 weeks, and 24 weeks. They will receive personalized nutritional counseling promoting a Mediterranean diet with a modest calorie deficit to support weight loss and healthy habits. The study follows participants for a total of one year to monitor their metabolic outcomes and responses to treatments such as lifestyle changes, medications, or bariatric surgery. Throughout the study, researchers will collect detailed data including blood counts, metabolic panels, inflammatory markers, and dietary intake. Participants will also receive motivational counseling to support adherence. The primary outcome is to assess the diagnostic and prognostic value of SII and SIRI at baseline, 24 weeks, and study completion after one year. This long-term follow-up will help determine if these indices can serve as useful clinical tools in managing obesity and its complications.