Puerto Colombia

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a chemotherapy payload, compared to treatment chosen by physicians including paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine for patients with first-line metastatic triple-negative breast cancer TNBC or low estrogen receptor ER-low, HER2-negative breast cancer who cannot receive anti-PDL1 or endocrine therapies. This study includes adults with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria. Participants are randomly assigned to receive iza-bren or one of the physicians choice chemotherapy regimens. The treatments are given at specified doses on scheduled days. The study includes two phases Phase 2 to determine the recommended dose of iza-bren and Phase 3 to compare progression-free survival and other outcomes. The study will last several years, with follow-up extending up to approximately 47 months after randomization. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests, and monitoring for adverse events. Quality of life questionnaires will also be completed. Researchers will track progression-free survival, overall survival, treatment-related side effects, tumor size changes, and patient-reported outcomes to evaluate the treatments. The total participation duration may extend up to several years depending on treatment response and follow-up requirements.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating plozasiran in adults with severe hypertriglyceridemia SHTG who have experienced at least two prior acute pancreatitis AP events, with one event occurring within the last 12 months before screening. The study aims to assess the efficacy and safety of plozasiran compared to a placebo in reducing AP events and managing triglyceride levels. About 288 adult participants will be involved in this randomized, double-blind, phase 3 clinical trial. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months Q3M. They will be counseled to maintain a low-fat diet and continue their prescribed lipid and triglyceride-lowering medications throughout the study. After the double-blind treatment period or upon experiencing a confirmed AP event, participants will enter a 12-month open-label extension, receiving plozasiran 25 mg by subcutaneous injection every three months. During the study, participants will be regularly monitored for the time to first AP event, changes in fasting serum triglyceride levels, cardiovascular events, patient-reported productivity, and health status. Safety assessments will include tracking treatment-emergent adverse events. The study will last approximately up to 62 months, including the double-blind and open-label phases, with ongoing evaluations and follow-up visits to assess treatment effects and participant health.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.