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Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are conducting a phase 3 randomized, double-masked clinical trial to compare the effects of two treatments, EYP-1901 and Aflibercept, for patients with diabetic macular edema DME. This study aims to evaluate which treatment better improves visual acuity in people affected by this condition. EyePoint Pharmaceuticals, Inc. is leading this study to assess these injectable drugs impact on vision. Participants will receive either EYP-1901 or Aflibercept through intravitreal injections directly into the eye. The study uses a parallel assignment design with participants randomized to one of the two treatment groups. The trial is double-masked to ensure unbiased results, and the primary treatment period focuses on 52 to 56 weeks of follow-up after injections. During the study, participants will have their best-corrected visual acuity measured to assess changes in vision. Researchers will also monitor the frequency of injections required over the 56-week period to evaluate treatment burden. Participants will attend regular study visits for these assessments and safety monitoring throughout the trial duration, which ends in October 2028.

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.

Researchers are evaluating the long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia HeFH or HoFH. This open-label, single-arm, multicenter extension study includes participants who have completed prior pediatric ORION studies ORION-16, ORION-13, ORION-20, or ORION-19. The trial aims to provide continued access to inclisiran treatment while monitoring safety outcomes over an extended period. Participants receive inclisiran injections, with dosing based on their previous study participation and weight. Those from ORION-16 or ORION-13 receive a 300 mg dose equivalent to 284 mg inclisiran in a 1.5 mL solution. Participants from ORION-19 and ORION-20 receive weight-based dosing. The study allows ongoing treatment with inclisiran to assess long-term effects and tolerability. During the study, participants are monitored for treatment-emergent adverse events and serious adverse events from day one through up to 1080 days. Researchers also measure changes in LDL cholesterol levels from the baseline of the prior studies to the end of this extension. The involvement includes regular safety assessments and evaluations to ensure participant well-being throughout the study duration, which may last nearly three years.

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 how a new combination treatment of Sigvotatug Vedotin plus pembrolizumab works compared to pembrolizumab alone in adults with non-small cell lung cancer NSCLC who have high levels of the PD-L1 protein. This protein can limit the bodys immune response to cancer. The study includes participants with advanced NSCLC who meet specific molecular and staging criteria and aims to assess the treatments effects on survival and disease progression. Participants receive pembrolizumab as an intravenous infusion once every 6 weeks at the clinic. Half of the participants will also receive Sigvotatug Vedotin intravenously every 2 weeks alongside pembrolizumab. Pembrolizumab treatment may continue for up to about two years, whereas Sigvotatug Vedotin administration can continue until the cancer no longer responds. The trial is randomized and controlled, comparing the combination treatment to pembrolizumab alone. During the study, participants attend regular clinic visits for treatment and monitoring. Researchers will evaluate overall survival and progression-free survival over approximately two years, along with additional measures such as response rates, duration of response, safety, and drug levels in the blood. The study includes ongoing assessments to observe how participants respond to treatment and manage side effects, with a total participation time that may extend up to several years.