Neuss

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are studying a new medicine called NNC0363-1063 in adults with type 1 diabetes to understand how it interacts with a non-glucose carbohydrate found in food and beverages. The study aims to see if taking these together is safe and well tolerated. This is a Phase 1 clinical trial involving participants aged 18 to 64 with type 1 diabetes for at least one year and who have been on insulin therapy for at least 90 days. Participants will receive a fixed dose of NNC0363-1063 via subcutaneous injection and will take varying amounts of the non-glucose carbohydrate by mouth in four separate interaction tests given in random order. The study treatment and testing period will last about 5 to 12 weeks. The focus is on understanding how the drug and carbohydrate affect the body's glucose handling when taken together. During the study, researchers will monitor participants' glucose infusion rates over time to assess the drug's pharmacodynamics and pharmacokinetics. Safety and tolerability will also be closely observed throughout the trial. Participants will undergo assessments at scheduled visits, including blood tests, and the total study duration will be up to 12 weeks to capture these measures and monitor their health.

Researchers are testing a new medicine called NNC9733-0001 to see if it can help treat people with type 2 diabetes by lowering high blood sugar levels. The study aims to evaluate the safety and how well the body tolerates this medicine. Participants include both healthy individuals and people with type 2 diabetes, and the study is a Phase 1 trial lasting about 40 weeks (10 months). Participants will receive either the study medicine NNC9733-0001 or a placebo (a treatment with no active medicine), assigned randomly. The medicine is given as one dose injected into the area around the belly by medical staff. The number of injections, up to four, depends on the dose group assigned, with larger doses requiring multiple injections. During the study, researchers will monitor participants closely through medical history, physical exams, vital signs, electrocardiograms, and laboratory tests. They will track any treatment-emergent adverse events and episodes of low blood sugar from the first dose until the end of the study at week 36. Overall participation involves several assessments to evaluate safety and medication effects over the study duration.

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are investigating how the drug LY3938577 is absorbed into the bloodstream and how long it stays in the body. Later phases of the study will compare the blood sugar lowering effects and duration of LY3938577 to Insulin Degludec. The study also aims to assess the safety and tolerability of LY3938577 by collecting information on any side effects experienced by participants. The study is divided into four parts (A, B, C, and D). In Part A Period 1, healthy participants receive a single intravenous (IV) dose of LY3938577 or placebo. In Part A Period 2, they receive a single subcutaneous (SC) dose of LY3938577 or placebo. Participants with Type 1 Diabetes Mellitus (T1DM) in Part B receive single IV doses of LY3938577 or Insulin Degludec. Those in Part C receive two SC doses of LY3938577 or Insulin Degludec. Part D includes two study periods: the first establishes insulin needs using basal insulin and lispro mealtime insulin, and the second administers lispro insulin with daily doses of LY3938577. Participants will be involved for up to approximately 11 weeks in Part A, 10 weeks in Part B, 13 weeks in Part C, and 10 weeks in Part D, including screening periods. During the study, researchers will monitor adverse events, vital signs, safety lab results, and drug levels in the blood. They will also evaluate pharmacokinetics, pharmacodynamics, and any clinically significant changes. This comprehensive monitoring will help understand LY3938577's safety, tolerability, and effects on blood sugar control.

Researchers are studying LY4057996 to understand how well it is tolerated and to track any side effects in healthy people and those with Type 1 or Type 2 Diabetes. This Phase 1 study includes participants with diabetes who meet specific health criteria, including blood sugar levels and insulin use. The goal is to assess the safety, how the drug moves through and is processed by the body, and its effects on the participants. Participants will receive LY4057996 either under the skin (subcutaneously) or into a vein in the arm (intravenously). Some will receive placebo treatments for comparison. Additional diabetes treatments such as Degludec or Lispro insulin may also be used depending on the participant group. The study is divided into parts lasting from 4 to 11 weeks, excluding a screening period, to evaluate the drug in different participant groups and dosing methods. During the study, participants will have blood tests to measure the drug levels and how long it stays in the body. Researchers will monitor for serious side effects and any other adverse events related to the drug from the start to the end of the study, which can last up to 47 weeks. Other assessments include physical exams, laboratory tests, and cardiac screening to ensure participant safety and collect detailed data on the drug's effects.

This research aims to evaluate the impact of retatrutide on insulin secretion and insulin sensitivity in adults with Type 2 Diabetes Mellitus (T2DM). The primary goal is to compare retatrutide with a placebo by measuring changes in total clamp disposition index after 28 weeks of treatment. Participants are adults diagnosed with T2DM who meet specific health criteria, including HbA1c levels and stable body weight. Participants receive injections under the skin of retatrutide, semaglutide, or a placebo as part of the study treatments. These are administered subcutaneously, and the study is conducted as a Phase 1, blinded trial to assess how retatrutide affects alpha and beta cell function and insulin sensitivity over the 28-week period. During the study, participants undergo various assessments including blood sampling to monitor insulin function and sensitivity. Researchers track changes from baseline in total clamp disposition index to evaluate outcomes. Safety is monitored through clinical laboratory tests and evaluations of any adverse effects. The entire participation lasts about 28 weeks, during which detailed clinical and laboratory evaluations are performed to understand the treatment effects.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating the safety, tolerability, and effects of AZD9550 alone and in combination with AZD6234 in people who are overweight or living with obesity, with or without type 2 diabetes (T2DM). This Phase I/II study includes participants aged 18 to 65 years for most parts and up to 75 years in some parts. The study aims to understand how AZD9550 is absorbed, distributed, and eliminated in the body and to assess safety when given alone or with AZD6234, especially in those with T2DM and obesity or overweight. The study is divided into multiple parts with different dosing schedules: Parts A-D investigate AZD9550 alone with doses increasing weekly or every few weeks; Part E studies the combination of AZD9550 and AZD6234 with increasing doses every 2 to 4 weeks; and Part F examines different ways to increase AZD9550 doses in participants without T2DM. Placebo injections matching the active treatments are used for comparison. Treatments are given as weekly subcutaneous injections. Participants will be closely monitored through various assessments including vital signs, ECGs, laboratory tests, and safety evaluations from screening until Day 261. Researchers will measure the number and percentage of participants experiencing adverse events, changes in lab or heart monitoring results, and the pharmacokinetics of AZD9550 such as concentration and elimination over time. The study also tracks tolerability and any treatment-related effects throughout the study duration.