Almeria

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 observing the use of the drug elafibranor in people with Primary Biliary Cholangitis (PBC), a rare and progressive liver disease where bile ducts are damaged. This damage can lead to scarring of the liver (cirrhosis) and is often linked with symptoms like itching and fatigue. If PBC worsens, it may require a liver transplant or could be fatal without one. The study aims to understand how effective, safe, and tolerable elafibranor is for those being treated in everyday clinical settings. Participants in this study will be those who have been diagnosed with PBC and are either starting or already receiving treatment with commercial elafibranor at a dose of 80 mg per day. The study is non-interventional, meaning it observes participants as they receive their usual care without altering treatment. The total study duration for each participant is approximately 60 months, or 5 years. During the study, researchers will gather information about participants’ responses to treatment, safety, and tolerability over time. Outcome measurements include the percentage of participants who respond to treatment after 6 months. Participants and their caregivers may complete questionnaires, and researchers will monitor treatment effects and side effects throughout the study period to better understand how elafibranor works in real-world use.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Parkinson's disease (PD) is a neurological condition that affects the brain, causing symptoms such as tremors, stiffness, and slow movement. This research aims to evaluate changes in sleep disturbances in adults with advanced Parkinson's disease who are receiving subcutaneous Foslevodopa/Foscarbidopa treatment. The study focuses on participants diagnosed with levodopa-responsive idiopathic Parkinson's disease experiencing severe motor fluctuations and hyperkinesia or dyskinesia. Participants will be treated with Foslevodopa/Foscarbidopa via subcutaneous infusion as prescribed by their doctors under routine clinical practice. Approximately 103 adults will be enrolled from around 20 sites across Spain. The treatment will follow the approved summary of product characteristics, and participants will be observed for up to approximately 12 weeks. During the study, participants will attend regular hospital or clinic visits according to their usual care schedule. Researchers will assess changes in Parkinson's disease-related sleep disturbances using the Parkinson's Disease Sleep Scale - 2 (PDSS-2). Cognitive function, treatment adherence, and any contraindications will also be monitored to ensure participant safety and study compliance throughout the observation period.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

Researchers are studying the safety and effects of an investigational medicine called PF-08653944 in adults who are overweight or have obesity along with type 2 diabetes. This condition involves carrying too much body weight and having high blood sugar levels. The study is a phase 3, multi-center, randomized placebo-controlled trial that aims to evaluate the medicine's ability to help with weight loss and monitor its safety. Participants will receive either the study medicine or a placebo by weekly injections under the skin in the belly area. About two-thirds of participants will get the study medicine, while one-third will receive the placebo. Participants will be trained to administer the injections themselves at home. The study will last about 21 months and includes up to 14 visits to the study site and 5 phone calls. During the study, participants will be closely monitored through visits and phone contacts. Researchers will measure changes in body weight from the start to week 64 to evaluate effectiveness. The study will also include assessments of safety and treatment effects over the entire duration. Participants need to perform finger-stick glucose monitoring as required and follow the study procedures throughout the trial.