Fremont

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 CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating the long-term safety and efficacy of plozasiran in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). This open-label Phase 3 extension study includes participants who completed prior related studies and meet specific medical and eligibility criteria, including controlled HbA1c levels. The trial aims to monitor treatment-emergent adverse events and changes in various lipid and cardiovascular markers over 24 months. Participants will receive eight doses of plozasiran, given by subcutaneous injection approximately every three months for two years. Throughout the study, participants are advised to maintain a low-fat diet consistent with local standard care. Additional criteria apply for certain participants transitioning from earlier studies, ensuring proper health status and treatment history. During the study, participants will undergo regular assessments including blood tests to measure triglycerides, cholesterol types, apolipoproteins, and HbA1c. Researchers will also track cardiovascular events, anti-drug antibodies, and any emergent need for apheresis. The trial spans 24 months with continuous monitoring of safety and lipid-related outcomes to understand the long-term effects of plozasiran treatment.

Menstrual migraine is a type of headache that occurs around the time of menstruation, often causing moderate to severe pain on one side of the head, sometimes with nausea, vomiting, or sensitivity to light and sound. This trial is investigating the safety and effectiveness of ubrogepant, an oral drug, to prevent menstrual migraines. Researchers will assess changes in migraine frequency and adverse events during the study. Participants will be randomly assigned to receive either ubrogepant or a placebo once daily for 7 days starting 3 days before their expected menstrual period, repeated for three menstrual cycles during a 16-week double-blind phase. Those who qualify may continue taking ubrogepant for up to 52 weeks in an open-label extension phase. The study involves about 496 adult female participants across multiple sites in the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will conduct medical assessments, blood tests, and questionnaires to monitor treatment effects, side effects, and changes in disease activity. The main outcomes measured include the change in the number of migraine days during the menstrual period and the number of participants experiencing adverse events over the course of the trial.

Researchers are evaluating the effectiveness, safety, and tolerability of HM15275 in adults with type 2 diabetes mellitus (T2DM) who have inadequate blood sugar control. This Phase 2 study focuses on adults aged 18 to 75 years with a body mass index between 25 and 50 kg/m² and HbA1c levels between 7.0% and 10.0%. The study aims to assess whether HM15275 can improve blood sugar levels over 36 weeks compared to a placebo. Participants will be randomly assigned to one of four groups, receiving either HM15275 or a placebo via weekly subcutaneous injections during the 36-week treatment period. Before treatment, all participants will complete a 4-week screening phase to confirm eligibility. After the treatment period, there will be a 4-week safety follow-up to monitor any side effects or health changes. During the study, participants will have regular visits to monitor their blood sugar levels using glycated hemoglobin (HbA1c) tests, assess safety through reports of adverse events, and evaluate overall treatment effects. The total participation lasts 44 weeks, including screening, treatment, and follow-up. Researchers will carefully track changes in HbA1c and any side effects to understand the treatment’s impact.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in people with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on patients with advanced NSCLC (Stage 3 or 4) where PD-L1 is present in at least 50% of the cancer cells. The aim is to see how these treatments work as first-line therapy for this type of lung cancer. Participants will receive pembrolizumab through an intravenous infusion every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin every 2 weeks by intravenous infusion alongside pembrolizumab. Pembrolizumab treatment can continue for up to about two years, while those receiving Sigvotatug Vedotin may continue until their cancer no longer responds to the treatment. During the study, participants will visit the clinic regularly for monitoring and treatment. Researchers will measure overall survival and progression-free survival, with assessments done by independent review and investigators over approximately two years and up to four years for some outcomes. They will also track responses to treatment, side effects, and drug levels in the blood to better understand how the treatments affect patients with NSCLC.

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.