El Salitre

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating whether treatment with both mirikizumab and tirzepatide compared to mirikizumab and placebo can reduce or eliminate symptoms of moderately to severely active ulcerative colitis UC in adults who are also overweight or have obesity. This Phase 3b randomized controlled study aims to determine if this combination treatment leads to clinical remission and at least a 10% reduction in body weight. Participants receive mirikizumab initially by intravenous IV infusion followed by subcutaneous SC injections. They are randomly assigned to receive either tirzepatide SC or a placebo SC alongside mirikizumab. The treatment period lasts for 52 weeks, with the whole study participation lasting up to 61 weeks. Both study drugs and placebo are administered under medical supervision. During the study, participants are monitored regularly for symptom improvement and weight loss. Researchers assess clinical remission, endoscopic response, histologic-endoscopic mucosal improvement, bowel movement urgency, and histologic remission at weeks 24 and 52. Safety and treatment effects are carefully followed throughout the trial. Participants undergo evaluations to measure changes in UC symptoms and body weight over the study period.

Researchers are evaluating the effectiveness and safety of mirikizumab combined with either tirzepatide or a placebo in adults with moderately to severely active Crohns disease who also have obesity or are overweight. This Phase 3b study aims to compare these treatments in participants who have a confirmed diagnosis and meet specific disease activity and weight criteria. The study is conducted by Eli Lilly and Company and lasts up to 61 weeks. Participants receive mirikizumab initially via intravenous infusion, followed by subcutaneous injections. They are randomly assigned to receive either tirzepatide with mirikizumab or placebo with mirikizumab, both administered subcutaneously. The study involves two experimental groups where treatments are given according to this schedule. During the study, participants will undergo regular assessments to monitor clinical remission using the Crohns Disease Activity Index and endoscopic remission, as well as track weight reduction. Evaluations include inflammatory bowel disease questionnaires and monitoring of corticosteroid use. The main measure is the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight loss by week 52. Safety and maintenance of remission are also assessed throughout the trial.