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Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK4/6 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctor's choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating the medicine PF-08046054 compared to the standard treatment docetaxel for adults with non-small cell lung cancer (NSCLC) that has PD-L1 expression of 1% or higher. This study focuses on participants whose cancer has spread or cannot be removed by surgery or treated with radiation, and who have progressed after treatment with PD-L1 or PD-1 inhibitors, platinum chemotherapy, and targeted therapies when applicable. The study is a randomized, phase 3 trial sponsored by Pfizer. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will have an intravenous infusion twice every 21 days, while those in the docetaxel group will receive one infusion every 21 days. Treatment may continue for up to five years if the cancer responds well. The treatments are given in cycles with close monitoring. During the study, participants will visit the clinic regularly for evaluations to monitor their health and response to the study treatments. Researchers will assess overall survival over about five years and track disease progression, response rates, duration of response, and quality of life measures. Safety will be monitored through adverse event reporting for up to 90 days after treatment ends. Additional blood tests will measure drug levels and antibody responses during the first year of treatment.

Researchers are evaluating combination therapies involving adagrasib with pembrolizumab and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and varying levels of PD-L1 expression. This Phase 2 open-label trial focuses on first-line treatment for patients with tumors showing PD-L1 tumor proportion scores (TPS) of 1% or higher, including those with TPS below 50%. The study aims to assess clinical responses and progression-free survival in this specific population. Participants receive adagrasib orally at 400 mg twice daily, combined with pembrolizumab given intravenously every three weeks, with treatment duration varying by cohort. Some cohorts also include chemotherapy agents such as pemetrexed, cisplatin, or carboplatin administered every three weeks. Treatment regimens differ across three cohorts, with some participants receiving adagrasib alone initially, followed by combination therapy, and others receiving concurrent combination treatments for up to 31 or 35 cycles. During the study, participants undergo evaluations including imaging to measure tumor response according to RECIST criteria, safety monitoring for adverse events, and pharmacokinetic assessments. The main outcomes measured are objective response rate and progression-free survival at six months, with additional monitoring of overall survival and duration of response. The study lasts up to 30 months, providing detailed data on treatment effects and safety in this patient group.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.

Researchers are evaluating the new medicine PF-08634404 combined with chemotherapy compared to the current standard treatment pembrolizumab with chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This phase 3, double-blind, randomized study focuses on adults 18 years or older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and who have not received prior treatment for advanced disease. Participants are divided into two parts based on tumor type: squamous NSCLC (Part 1) and non-squamous NSCLC (Part 2). Each participant is randomly assigned to receive either PF-08634404 or pembrolizumab along with a chemotherapy regimen specific to their tumor type. Treatments are given through intravenous infusions in cycles, with maintenance therapy continuing if the treatment is effective and side effects are manageable. Throughout the study, participants will attend regular visits for treatment administration and health monitoring. Cancer response will be assessed every 6 weeks during the first 48 weeks, then every 12 weeks thereafter. Researchers will measure overall survival, progression-free survival, response rates, quality of life, and safety through various assessments including imaging, laboratory tests, and questionnaires over approximately 32 to 39 months of follow-up.

Researchers are evaluating the safety, tolerability, and recommended Phase 2 dose of TTX-080, an HLA-G inhibitor, alone and in combination with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. This Phase 1, open-label trial includes patients with advanced refractory or resistant solid cancers, such as metastatic colorectal cancer and other types like head and neck squamous cell carcinoma, non-small cell lung cancer, triple-negative breast cancer, renal cell carcinoma, and acral melanoma. The study consists of dose escalation and dose expansion phases. Participants may receive TTX-080 as monotherapy or combined with pembrolizumab (a PD-1 inhibitor), cetuximab (an EGFR inhibitor), or FOLFIRI plus cetuximab chemotherapy regimens. Different arms focus on specific cancer types and treatment histories, including randomized arms comparing TTX-080 with FOLFIRI plus cetuximab versus FOLFIRI plus cetuximab alone for metastatic colorectal cancer patients. Participants will undergo assessments over up to 48 months, including tumor response evaluations using RECIST 1.1 criteria, pharmacokinetic and immunogenicity testing, and monitoring for adverse events and tolerability. Researchers will track various outcomes such as duration of response, progression-free survival, overall survival, and drug concentration levels to understand TTX-080's activity and safety profile.

Researchers are evaluating whether the drug zilebesiran can reduce major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, and heart failure episodes 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 gather sufficient clinical outcome events to determine the drug's impact compared to placebo. Participants will receive either 300 mg of zilebesiran or a placebo through subcutaneous injection every six months, in addition to their usual antihypertensive medications that include at least two standard drugs, one being a diuretic. The study treatments are given as add-on therapy alongside the participants' existing blood pressure management. The study will continue until enough cardiovascular events have occurred to assess the primary outcome. During the study, participants will be monitored for up to approximately five years. Researchers will track the time to the first occurrence of a combined endpoint including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events requiring hospitalization or urgent visits. Blood pressure changes will also be measured at six months. Safety and efficacy will be closely followed through regular visits and assessments. The long follow-up period allows for thorough evaluation of cardiovascular outcomes and treatment effects.