Neuss

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating the safety, tolerability, and effectiveness of NNC0497-0040 in healthy adults with normal weight or overweight, adults with overweight or obesity, and adults with type 1 diabetes who also have overweight or obesity. This phase 1 clinical trial aims to understand how this new treatment compares to a placebo in these different groups. The sponsor of the study is Novo Nordisk AS. Participants will receive weekly subcutaneous injections of either NNC0497-0040 or a matching placebo. The study includes multiple groups single ascending dose SAD and multiple ascending dose MAD cohorts. Each participant will receive either the investigational drug or placebo for up to 29 weeks, depending on their assigned group. During the trial, participants will have regular assessments including medical exams, vital signs, electrocardiograms, and laboratory tests to monitor safety and drug effects. Researchers will track the number of adverse events from the start of treatment through various weeks depending on the cohort, along with measuring drug levels in the blood. Participants glucose control and hypoglycemic episodes will also be monitored, especially for those with type 1 diabetes. The total participation time may last up to 29 weeks.

Researchers are evaluating a new medicine called NNC9733-0001 for its potential to help people with type 2 diabetes manage high blood sugar levels. The study also includes healthy participants to compare safety and tolerance. This Phase 1 trial aims to assess how safe and tolerable the medicine is when given as a single dose. Participants will be randomly assigned to receive either the study medicine or a placebo, which contains no active medicine. The dose strength is determined by when the participant enters the study, and the medicine is given as one or up to four injections around the abdomen by medical staff. The total study duration is about 40 weeks 10 months. During the study, participants will be monitored for side effects and any low blood sugar events from dosing until the end of the study at week 36. Blood samples will be collected to measure how the medicine behaves in the body over 48 hours after dosing. Participants will have regular assessments including physical exams, vital signs, ECGs, and laboratory tests to track safety and how the medicine is processed. The study includes healthy volunteers and people with type 2 diabetes aged 18 to 64 years.

Researchers are evaluating the safety, tolerability, and how the body processes the drug ZP6590 in adult men who are healthy and have a normal weight, are overweight, or have obesity. This randomized, double-blind, placebo-controlled trial aims to understand if ZP6590 is safe and well tolerated when given as increasing single and multiple doses. The study also investigates how quickly and to what extent the drug is absorbed, distributed, and eliminated from the body. The trial has two parts. In the first part, participants receive a single subcutaneous dose of ZP6590 or placebo followed by a 4-week observation period. In the second part, participants receive multiple subcutaneous doses of ZP6590 or placebo for either 6 or 12 weeks, followed by a 6-week observation period after the last dose. Participants are admitted to the study site before dosing and may have ambulatory visits or stay under in-house conditions after dosing. Safety and drug exposure are evaluated before increasing to the next dose level. Participants will undergo screening to confirm eligibility before enrollment. During the study, safety assessments, blood tests, and pharmacokinetic evaluations are performed regularly to monitor the drugs effects and how it is processed in the body. The main outcomes measured are safety and tolerability over the dosing and observation periods. Participants involvement lasts up to 18 weeks depending on the dosing schedule, including observation periods following dosing.

Researchers are evaluating the clinical and health-related outcomes of amivantamab-containing treatment regimens for patients with common EGFR-mutated advanced non-small cell lung cancer NSCLC, including metastatic cases where the cancer has spread. This study observes these treatments in a real-world setting, focusing on patients with specific EGFR mutations exon 19 deletions or exon 21 L858R substitution. It aims to describe how these regimens perform outside of controlled clinical trials. Participants are grouped into two cohorts one receiving amivantamab combined with carboplatin and pemetrexed after prior therapy failure, and another receiving amivantamab with lazertinib as first-line therapy. Treatments are given according to usual clinical practice, and no study drugs are provided. Data collection captures information from routine care, including treatment administration and related medications. During the study, researchers collect data on treatment duration, progression-free survival, overall survival, adverse events, dose changes, concomitant medication use, and quality of life measures using validated questionnaires. Monitoring continues for up to approximately 60 months. Participants provide informed consent, and all data comes from standard medical records without additional interventions or procedures required by the study.

Researchers are studying the effects of eloralintide compared to a placebo on insulin sensitivity, metabolic health, and body weight in adults who are overweight or have obesity. This phase 1 study focuses on understanding how these treatments influence how the body responds to insulin and other metabolic factors. Participants in this study are adults aged 18 to 70 years with a body mass index between 25 and 45 kgm, and without diabetes. Participants will be randomly assigned to receive either eloralintide or a placebo, both administered by subcutaneous injection. The study lasts about 35 weeks and includes 3 inpatient visits totaling 7 days. The design is double-blind, so neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, participants will undergo assessments to measure changes in insulin sensitivity using a hyperinsulinemic euglycemic clamp test at baseline and week 24. Body weight changes will also be tracked over the same period. Participants must maintain lifestyle and dietary guidelines throughout the study. The research team will monitor safety and overall health during the visits and follow the participants until study completion around 2027.

Researchers are studying LY3938577, a drug being evaluated in healthy individuals and people with Type 1 Diabetes Mellitus T1DM. The study aims to understand how much LY3938577 enters the bloodstream and how quickly the body eliminates it. Later parts of the study will compare LY3938577s blood sugar-lowering effects and duration of action against Insulin Degludec. Safety and side effects will also be monitored throughout the study. The study has four parts A, B, C, and D. In Part A, healthy participants receive single doses of LY3938577 or placebo either intravenously or subcutaneously. Participants with T1DM in Parts B and C receive LY3938577 or Insulin Degludec intravenously or subcutaneously, with controlled insulin dosing to maintain glucose levels. Part D evaluates participants with T1DM receiving basal and mealtime insulin doses along with LY3938577. Each part lasts between 10 and 13 weeks, including screening. Participants will have blood tests to measure drug levels, safety labs, vital signs, and glucose control. Researchers will track any adverse events and monitor how the drug affects blood sugar using glucose infusion rates. Participants may undergo exercise challenge tests in Part D. The study includes regular visits and assessments over several weeks to collect data on safety, tolerability, pharmacokinetics, and pharmacodynamics of LY3938577.

Researchers are evaluating the safety, tolerability, and effects of LY4057996 in healthy adults and adults with Type 1 or Type 2 Diabetes. This Phase 1 study aims to understand how well the drug is tolerated and what side effects may occur. It also investigates how LY4057996 is absorbed and eliminated in the body through blood tests. The study is sponsored by Eli Lilly and Company and includes multiple parts with varying durations and participant groups. Participants will receive LY4057996 or placebo either subcutaneously under the skin or intravenously into a vein. Some groups may also receive other insulin treatments such as basal insulin, Lispro, or Degludec. The study is divided into several parts Part A lasts about 11 weeks, Parts A3 to A5 last about 4 weeks, Part B lasts about 6 weeks, and Part C lasts about 7 weeks, not including a screening period. Different parts include different dosing schedules and combinations of study drugs and insulin therapies. During the study, participants will undergo regular blood tests to measure drug levels and effects on glucose control. Researchers will monitor for any serious or related side effects throughout the study period, which can last up to 47 weeks. Other assessments include measuring fasting glucose and glucose infusion rates. Participants will be closely observed to ensure safety and to collect detailed information about how LY4057996 works in the body.

Researchers are evaluating the real-world effectiveness of asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This observational study compares patients who are newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor TKI to those treated with other TKIs. The study aims to assess tolerability, safety, and molecular response outcomes in routine clinical care. Participants are grouped into cohorts based on their treatment those receiving asciminib, those newly diagnosed treated with imatinib, and those newly diagnosed treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by physicians prior to enrollment, and treatment must not have started more than 14 days before joining the study. The study follows patients over time to document treatment patterns, dose changes, interruptions, and discontinuations. Participants will attend routine follow-up visits and complete patient-reported outcome questionnaires assessing medication adherence, quality of life, and work productivity at multiple time points up to 24 months. Researchers will measure major molecular response at 12 months as the primary outcome and evaluate various secondary molecular responses, reasons for treatment changes, and quality of life scores. The study duration extends through September 2030, allowing long-term observation of treatment effectiveness and safety.