Blackburn

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Sepsis is a serious condition caused by the bodys extreme response to an infection, leading to tissue and organ damage. This research compares two early treatment methods for sepsis immediately after hospital arrival, focusing on whether starting vasopressor medication right away or beginning with fluid therapy improves patient recovery and reduces complications. The study is a Phase 3 trial aimed at finding the best approach to improve outcomes for adults with septic shock. Participants are divided into two groups one receives a continuous peripheral vasopressor infusion of norepinephrine during the first 48 hours, while the other group receives standard care guided by UK NICE and Surviving Sepsis Campaign guidelines, which starts with intravenous fluids and adds vasopressors as needed. Both treatments follow local hospital protocols beyond the initial interventions. During the study, participants will be closely monitored for blood pressure, fluid volume, lactate levels, and other health indicators at multiple time points up to 90 days after randomization. Researchers will assess outcomes including hospital stay length, need for additional therapies like renal replacement or respiratory support, and overall survival. Quality of life and readmission rates will also be evaluated to understand the longer-term effects of the treatments.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating whether post-operative antibiotics are necessary following surgery for patients with mandible fractures. This trial, known as the MANTRA trial, aims to determine if giving no antibiotics or different antibiotic regimens after surgery is as effective as the current common practice. The study addresses the concern of antibiotic overuse and resistance, as mandible fractures are common and often require surgery with titanium miniplates, which may risk infection. The trial compares three groups one receiving no further antibiotics after a single intravenous dose at surgery induction, another receiving two additional postoperative intravenous doses, and a third receiving two postoperative intravenous doses followed by a five-day course of oral antibiotics. All participants receive one dose of intravenous co-amoxiclav before surgery. This randomized, open-label, multicenter study will include an internal pilot phase to optimize recruitment and retention. Participants will be monitored for surgical site infections and other outcomes such as return to surgery, hospital stay length, complications, and quality of life up to 180 days after surgery. The study includes assessments of antibiotic exposure and cost-effectiveness. Data will be collected through hospital records and follow-ups, with a total trial duration extending through recruitment, treatment, and follow-up phases until the end of 2027.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.

Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.