El Salitre

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.