Fremont

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 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 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.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

Researchers are evaluating HM15275 in adults with type 2 diabetes mellitus who have inadequate blood sugar control. This Phase 2 clinical trial aims to assess the effectiveness, safety, and tolerability of HM15275 compared to a placebo over 36 weeks. Participants must be between 18 and 75 years old, have a body mass index between 25 and 50 kgm, and have specific blood sugar levels measured by HbA1c between 7.0% and 10.0%. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be randomly assigned to one of four groups, receiving either HM15275 or a placebo via weekly subcutaneous injections. The study includes a 4-week screening period to confirm eligibility, followed by a 36-week treatment phase where participants receive the injections. After the treatment phase, there is a 4-week safety follow-up to monitor any effects after stopping the medication. Randomization considers factors like initial HbA1c levels and whether participants are using metformin. Throughout the study, participants will attend regular visits for assessments. Researchers will measure changes in HbA1c to determine blood sugar control, track the percentage of participants reaching target HbA1c levels, and monitor any adverse events. Safety and tolerability are closely observed during the treatment and follow-up periods. The total participation time is approximately 44 weeks, including screening, treatment, and safety follow-up.

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.

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.