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Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

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 evaluating asthma control, health-related quality of life (HRQL), lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in a real-life clinical setting in Germany. This prospective, non-interventional, single-arm, multicenter study aims to observe these outcomes over a 52-week period to better understand benralizumab's impact outside of randomized clinical trials. Patients prescribed benralizumab according to label and local reimbursement criteria will be followed for up to 52 weeks. The study will monitor asthma control using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at various timepoints. Health-related quality of life will be assessed with the mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and routine follow-up visits. Patients will also track and report their weekly asthma medication intake using either paper-based or electronic diaries throughout the study. Participants will complete questionnaires every 4 weeks and record medication intake weekly. Researchers will measure changes in ACT scores, proportions of responders, and reductions in inhaled corticosteroid doses from baseline to weeks 12, 24, and 52. Safety and health outcomes will be observed under routine clinical care. This study includes adults aged 18 to 120 years with severe eosinophilic asthma who can understand study instructions and provide informed consent.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.